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SAFETY IV CATHETER, tip, 24G x 19 mm, wings, no IP, yellow

https://unicat.msf.org/cat/product/95539
STD SINSIVCST24W2

Valid Article

The product is supplied (and stored) sterile, it must remain sterile until its use. Sterile = state of being free from all living microorganisms.
Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
C0101010201 - Peripheral i.v. catheters, with safety systems, with injection valve
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
IIa
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
CT3+
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)
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SAFETY IV CATHETER, tip shield, 24G no IP

Definition

A sterile, thin, flexible tube intended to be inserted into the peripheral vasculature of a patient to enable short-term (< 30 days) intravascular access. It is not intended to be advanced to the central vasculature. It includes a stylet for catheter introduction and wings for fixation.

It is a safety injection device reducing the risk of needle stick injuries. It may be used to administer fluids/blood or medication.

This small size is specifically intended for neonatal use.

Specifications

Quality standards

  • EN ISO 10555-1, 2013, edition 3, +A1 2017 Sterile, single-use intravascular catheters - Part 1: General requirements
  • ISO 10555-5, 2013, edition 2, (confirmed 2018) Sterile, single-use intravascular catheters - Part 5: Over-needle peripheral catheter
  • ISO 23908, 2013, edition 1, Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling

Technical specifications

  • CATHETER
    • polyurethane (PUR) is the first choice material, FEP is the second choice option.
    • straight and tapered distal end
    • translucent hub with standardized colour code (ISO 10555-5) and female Luer connector
    • fitted with wings (Butterfly)
  • STYLET
    • stainless steel
    • slightly longer than the cannula
    • bevelled end
    • translucent hub (flashback chamber) to observe blood reflux
    • fitted with a stopper (flashplug)
  • PROTECTIVE SHEATH
  • SAFETY MECHANISM
    • While retracting the stylet from the catheter, a device is placed upon the tip of the stylet (shape of tip is brand specific, see picture)
    • Passif safety mechanism: the user does not have to activate the safety mechanism.
    • The safety tip protection remains in place once activated.
  • Size: 24G: external Ø = 0.74 mm, internal Ø = 0.55 mm, length = 19 mm, flow rate = +/- 23 ml/min, color = yellow
  • Sterile, for single use

Packaging & Labelling

Unit sterile packaging in peel-open pack

Instructions for use

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Precautions for Use

Ensure that the baby is warm when placing an IV line: if the baby is cold, the risk of vein rupture during the canalization is higher.

Be carefull with the use of a tourniquet: not too long and not too tight as this may also increase the risk of vein rupture. Option: ask the assistance of another colleague that uses her/his hand as tourniquet, so the pressure applied is much more controlled.

MSF requirements

IV catheter with passive safety mechanism for general use.

Change of specifications of the safety IV catheter 24G as we have received many quality complaints, from different brands. A technical cause was never identified, we try to facilitate the handling of the IV catheter during the insertion procedure by removing the injection port. The 24G catheter is quite small, so the side of the injection port complicates the handling and manipulation of the catheter during the insertion and fixation.

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