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PEN NEEDLE, 30-31G, 0.30-0.25 x 8mm

https://unicat.msf.org/cat/product/45190
STD SINSNEAI3008

Valid Article

Former Code(s): SINSZFR0074 SINSNEIP230 SINSINPE2N30 SINSINPE2N308 SINSZRU0009 SINSINAI2N308
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.
A0101010202 - Hypodermic pen needles, w/o 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.
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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AUTO INJECTOR NEEDLE

Definition

A device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector).

It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals.

This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected.

This device is packaged in a sealed sterility barrier. This is a single-use device.

Synonym

pen needle

Specifications

Image

Quality standards

  • ISO 11608-2, 2022, edition 3, Needle-based injection systems for medical use — Requirements and test methods — Part 2: Double-ended pen needles
  • ISO 7864, 2016, edition 4, (confirmed 2021) Sterile hypodermic needles for single use - Requirements and test methods

Technical specifications

  • pen needle that fits all major injector pens
  • Gauge: 28G - 32 G
  • length: 4 mm - 12 mm
  • with protection cap
  • sterile, single use

Instructions for use

To be used with a disposable pen containing a prefilled amount of insulin. When this type of pen is empty, it is thrown away.

Must be given as deep SC injection only.

Preparation for administration:

  • Wash hands.
  • Check the pen label (type and strength of insulin, expiry date) and the solution (cloudy, white and aqueous).
  • Stir the insulin by gently rolling the pen between the palms of the hands. Do not shake the pen.
  • Remove the cap from the pen.
  • Wipe the pen tip (rubber seal) with a disinfectant.
  • Attach a pen needle to the pen after removing the protective seal of the needle. Push the needle straight onto the pen. Screw the needle on the pen.
  • Remove the outer cap of the needle and save it (you will need it to remove the needle after the injection).
  • Remove the inner cap of the needle.
  • Remove air from the pen. Pointing the needle up in the air, select one or two units on the pen. Gently tap the pen to move air bubbles to the top of the pen.
  • Press the injection button. A drop of insulin should appear on the tip of the needle. If no drop appears, change the needle and repeat this step.
  • Select the correct dose on the pen. Turn the dose selector to the required number of units.

How to administer SC insulin:

  • Insulin can be injected into the abdomen (two fingers away from the belly button), upper arm, buttocks, hips, buttocks, or the front or side of the thigh.
  • Injecting insulin in the same area repeatedly can cause lumps, swelling and thickened skin, and it may keep insulin from absorbing properly. See the picture below on “rotating” injection sites.
  • Do not inject insulin into areas that have wounds or bruising.
  • Clean the chosen injection site with soap and water. Allow to dry.
  • Pinch the skin.
  • Keep the pen straight at a 90-degree angle to the skin and insert the needle with one quick motion.
  • Push the injection button with the thumb to inject the dose of insulin. Wait for 10 seconds before releasing the button and removing the needle from the skin.
  • Apply gentle pressure on the injection site with the finger for 5-10 seconds to keep insulin from leaking out.
  • Remove the needle from the pen by replacing the outer needle cap on and unscrewing. Leaving the needle on the pen can result in leakage or air bubbles.
  • Safety discard the needle into a sharps container.
  • Replace the pen cap.
Image

Precautions for Use

  • check compatibility with the injector pen
  • Make sure that along with rotating injection sites, you follow these rules for using needles correctly.
  • Use new needles either for every injection or at least change them once a day.
  • Do not inject through clothing

MSF requirements

for use with insulin pen

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