(blds.syst.) SAFETY SAMPLING SET, retractable, 23 G

STD STSSBSVSRS23

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.
A01010501 - Needles for collection under vacuum, with safety systems
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.
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
The order of this product needs to be justified and is only acceptable under certain conditions.
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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(blood sampling) SAFETY SAMPLING SET, retractable

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Definition

Winged blood sampling set with integrated active safety mechanism to retract the needle into the device. It is attached to an extension set. The device is to be used with standard sampling tubes.

Specifications

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Quality standards

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

  • Needle
    • 23G x 19 mm
    • Stainless steel
  • Wings
    • PVC, colour coded for the size of the needle (light blue)
    • indicating the gauge of the needle: 23G
  • Extension set
    • STSSBSVSRS23: +/- 18 cm tubing, priming volume = 0.225 ml. With multiple sample Luer adapter (see picture) allowing the use of a syringe or a regular tube holder (STSSBSVVH1-).
    • STSSBSVSRS23H: +/- 30 cm tubing, priming volume = 0.350 ml with attached tube holder.
  • Safety activation instantly retracts needle after use. Activation of the system by pushing the button on the hub of the needle.
  • Sterile, single use

Packaging & Labelling

Unit sterile packaging in peel-open pack

  • STSSBSVSRS23 : 50 / pack, 200 / box
  • STSSBSVSRS23H : 20 / pack, 100 / box

Instructions for use

Please consult the “Manual of nursing Care Procedures, MSF, 2020” available online via the Nursing care working Group sharepoint page.

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Precautions for Use

  • Using a syringe to draw blood may result in increased hemolysis.
  • Discard all blood collection "sharps" in biohazard containers for their disposal.
  • Always follow Universal Precautions.
  • Activation of the device while the needle is still in the venipuncture site is recommended. Activation of the device after the needle is removed from the site should be performed away from self and others, since external blood droplets/IV fluid droplets may result.

MSF requirements

  • No technique change, ease of use
  • Compatible with the standard blood sampling needles and tubes (Vacutainer)
  • Retractable system covering the whole needle after activation was selected as safety system for high risk context (VHF)
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