2 PentaFlush - Pre-Filled Saline Syringes

3PentaFerte - Medical Devices Solutions

Combining Safety and Efficiency for Optimal Patient Outcomes.Saline 0,9% NaCl Pre-Filled syringes for the

flushing of vascular access devices.

PentaFlush is a product made by PentaFerte.

4 PentaFlush - Pre-Filled Saline Syringes

Flushing a vascular access reduces the risk of*:

PHLEBITIS OCCLUSIONS

INFILTRATIONS INTRALUMINAL INFECTIONS

EXTRAVASATIONS DRUGS INTERACTION

*References 1, 2, 5, 6 at page 13

5PentaFerte - Medical Devices Solutions

6 PentaFlush - Pre-Filled Saline Syringes

7PentaFerte - Medical Devices Solutions

Advantages of a ready-to-use device VS a manually filled conventional syringe*:

TIME AND COST-SAVING

DISPOSAL REDUCTIONReduces waste of saline solution multidose containers.

STREAMLINING OF WARD PROCEDURES

NURSE WORKFLOW ENHANCEMENT

CRBSIs RISK REDUCEDReduces the risk of CRBSIs (Catheter Related Bloodstream Infections).

REDUCES THE RISK OF MEDICATION ERRORS

BACTERIAL CONTAMINATION REDUCTIONReduces the risk of bacterial contamination which may occur through the use of conventional multi-dose NaCl containers.

NEEDLE STICK INJURIES RISK ELIMINATIONEliminates the risk of needle stick injuries during preparation using a conventional syringe.

*References 1, 2, 3, 4, 5, 6 at page 13

8 PentaFlush - Pre-Filled Saline Syringes

AVAILABLE IN 4 SIZES3-5-10-20* ml

PACKAGING OPTIONS:1) Medical grade paper - Plastic film2) Aluminium pack

SUITABLE FOR STERILE FIELDSyringe and fluid path sterile

STANDARD 10 ML BARRELFOR 3-5-10 ML SIZESTo reduce internal pressure and avoid catheter damage**

Features:

*20 ml volume is recommended with blood sampling from CVC and Picc lines. References 1-7 at page 13.After infusion of viscous products like Contrast media, Blood components, Parenteral nutrition. Reference 8-9 at page 13.

**18.2 PSI = Inner pressure of the 10 ml PentaFerte syringe subjected to 5 lbs. axial force . Data on file available at PentaFerte. Reference 1 at page 13.

9PentaFerte - Medical Devices Solutions

PentuFlush Aluminium Pack. Packaging available also with Medical grade paper and Plastic film.

Aluminium Pack

10 PentaFlush - Pre-Filled Saline Syringes

Additional info:

DESIGNED AND MANUFACTURED IN ITALY

CLASS IIa MEDICAL DEVICE*

SINGLE-USE

SHELF LIFE: 3 YEARS

DURING THE SYRINGE MANUFACTURING PROCESS THE FOLLOWING SUBSTANCES ARE NOT USED OR INTENTIONALLY INCORPORATED INTO THEIR MATERIALS: DEHP, PVC, LATEX, PRESERVATIVES

*The prefilled syringe PENTAFLUSH classification as class 2a medical device according to MDD/93/42  meets the regulatory safety requirements applicable for its intended use.

11PentaFerte - Medical Devices Solutions

12 PentaFlush - Pre-Filled Saline Syringes

13PentaFerte - Medical Devices Solutions 13PentaFerte - Medical Devices Solutions

ITALY+39 0532 77 88 50

EXPORT+39 0532 77 88 16

EMAILinfo@pentaferte.com

WEBSITEwww.pentaferte.com

For ordering information please contact our customer service team.

REF. DESCRIPTION BOX CASE

060022420 3 ml pre-filled syringe 0,9% NaCl 30 120

060022520 5 ml pre-filled syringe 0,9% NaCl 30 120

060022620

060025420

060025620

060025520

060025720

060022720

10 ml pre-filled syringe 0,9% NaCl

3 ml pre-filled syringe 0,9% NaClAluminium Pack

10 ml pre-filled syringe 0,9% NaClAluminium Pack

5 ml pre-filled syringe 0,9% NaClAluminium Pack

20 ml pre-filled syringe 0,9% NaClAluminium Pack

20 ml pre-filled syringe 0,9% NaCl

30

30

30

30

20

20

120

120

120

120

80

80

Ordering:

References:1 Infusion Nurses Society Infusion Therapy Standard of Practice. Journal of Infusion Nursing. 2021 44 (1S) S113.2 Lynn Hadaway Flushing vascular access catheters: Risk for infection transmission. Infection Control Resource. Saxe Communications. 2007; 4(2). Available from: http://www.mghpcs.org/eed_portal/Documents/Central_Lines/CL_flushing_and_infection.pdf3 Basic Infection Control and Prevention Plan for Outpatient Oncology Settings. National Center for Emerging and Zoonotic Infectious Diseases (U.S.), Division of Healthcare Quality Promotion. October, 2011. Available from: https://www.cdc.gov/hai4 Bertoglio S, et al., Pre-filled normal saline syringes to reduce totally implantable venous access device-associated bloodstream infection: a single institution pilot study, Journal of Hospital Infection (2013). Available from: http://dx.doi.org/10.1016/j.jhin.2013.02.0085 Lynn Hadaway Misuse of prefilled flush syringes: implications for medication errors and contamination. Infect Control Resource. 2008; 4(4):2-4. Available from: https://hadawayassociates.com/uploads/3/5/4/4/35447364/misuse_of_prefilled_copy.pdf6 National Institute for Health and Care Excellence (NICE). Healthcare-associated infections: prevention and control in primary and community care Clinical guideline CG139 (1.4.4) March 2012. Available from: https://www.nice.org.uk/guidance/cg139/chapter/1-Guidance#vascular-access-devices 7 South Wales Intravenous Access Advisory Group. Guidelines for the Care and Maintenance of a Peripherally Inserted Central Catheter (Picc). Available from https://www.nice.org.uk/guidance/mtg34/resources/guidelines-for-the-care-and-maintenance-of-a-peripherally-inserted-central-catheter--velindre-cancer-centre-pdf-4481503170 8 Recommandations par consensus formalisé SF2H 2013 – Volume XXI – n°6 Bonnes Pratiques et gestion des risques associés au PICC. Decembre2013. Availables from https://sf2h.net/wp-content/uploads/2014/05/SF2H_bonnes-pratiques-et-gestion-des-risques-associes-au-PICC-2013.pdf9 GAVeCeLT. L’utilizzo dei PICC in nutrizione parenterale. Available from: https://gavecelt.it/nuovo/sites/default/files/uploads/utilizzo_dei_picc_in_nutrizione_parenterale.pdf

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14 PentaFlush - Pre-Filled Saline Syringes

Pentaferte Italia, part of a

pool of companies operating

in the medical and industrial

automation industry, certified

according to UNI CEI EN ISO

13485:2016, is leading in

the production of medical

devices for the hospital and

pharmaceutical market; it

cooperates with the major

world leaders in the medical

and pharmaceutical field,

focusing on the infusion world.

The synergy among the

companies in the group

increases the strength of

Pentaferte Italia, a solid

and reliable company,

able to find effective and

innovative solutions with

high technological content

for the specific needs of the

most demanding customers in

Europe and all over the world.

Pentaferte Italia also designs

and manufactures different

products for third parties,

taking care of every single

production phase.

Located in Italy, Pentaferte

operates worldwide. The

production site in Campli -

Teramo, 2 hours away from

Rome, is one of the largest

in Europe and is investing in

a deep revamping process in

order to comply with the most

demanding medical device

manufacturing requirements.

The activity of design and

manufacturing is its “DNA”

and over the years it has been

able to follow and anticipate

the market development in

terms of quality standards and

demand of safety products in

the medical world.

Given the extensive experience

and flexibility among its

manufacturing processes,

Pentaferte addresses also

to the B2B market, offering

devices under customized

design, with its own CE mark or

Customer’s one, with dedicated

packaging as well as any other

customization the customer

may need, in compliance with

Pentaferte technologies.

The Company

15PentaFerte - Medical Devices Solutions

QUALITY

INNOVATION

www.pentaferte.com

PentaFerte Italia Srl Unipersonale - VAT: IT01866900671

Registered Office & Production Site: Viale Piane Nocella, 23 - 64012 Campli (TE) - Italy

Commercial & Administrative Offices: Via Modena, 119 - 44122 Ferrara - Italy

Brochure Version 1.5 - 06/2021