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SUPRAPUBIC PUNCTURE SET, CH10, adult, sterile, s.u.

https://unicat.msf.org/cat/product/18284
STD SCTDCASP10A

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.
U0401 - Devices for suprapubic urinary drainage
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
PM
The order of this product needs to be justified and is only acceptable under certain conditions.
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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SUPRA-PUBIC CATHETER PUNCTURE SET

Definition

​A sterile, flexible/semi-rigid tube intended to be inserted through a suprapubic incision directly into the bladder of patient primarily for the drainage of urine. It consists of a straight single-lumen tube. The proximal end remains external to the patient and is connected to a urine collection device. It includes a trocar to assist in its insertion.

Specifications

Quality standards

ISO 20697, 2018, edition 1, (confirmed 2023) Sterile drainage catheters and accessory devices for single use

Technical specifications

  • Drainage catheter:
    • polyurethane (short and medium care) or silicone (long time care)
    • pigail- tip (J-tip) for minimum irritation of bladder
    • open distal end with lateral eyes
    • with clamp or plug
    • funnel shape connector for connecting to the bag
    • selected size: CH 10
    • length: ± 50 cm (40 - 70 cm)
  • Trocar = introducer:
    • stainless steel, cleavable (option = trocar in cannula that splits in two parts)
    • length: 8 to 12 cm
  • Sterile, for single use

Packaging & Labelling

Unit sterile packaging in peel-open pack

(Cf Introduction: Packaging and labelling)

To be Ordered Separately

Articles supplied with the puncture set are optional as available in health facilities where this procedure is carried out:

  • Urine bag:
    • PVC
    • graduated
    • capacity: 1 to 2 litres
  • Fixation device (surgical tape or fixation disc) to hold the catheter firmly in place on the skin
  • scalpel

These articles may be included or not, depending on the manufacturer.

Instructions for use

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Precautions for Use

Available suprapubic catheter kits vary considerably in their composition. Read carefully the package insert that comes with the kit. Check for exact content, some articles are optional and have to be added from the hospital stock.

Immediately after use, dispose of the trocar into a sharps container (see related articles below).

(Cf Public Health Engineering In Precarious Situations, MSF, 2010, Chapter 6)

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