BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX PRO-VENT ARTERIAL BLOOD SAMPLING KIT

    MDR report key: 385338 · Received March 22, 2002

    Report

    Report Number
    MW1024526
    Event Type
    Malfunction
    Date Received
    March 22, 2002
    Date of Event
    March 4, 2002
    Report Date
    March 22, 2002
    Manufacturer
    SIMS PORTEX
    Product Code
    CBT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    RESPIRATORY THERAPIST NOTICED THAT ABG KIT WAS DEFECTIVE WHERE THE NEEDLE IS SCREWED INTO THE HUB. DEFECTIVE KIT HAS AN OBLONG HUB, WHICH SHOULD BE ROUND. THE HUB DOES NOT SEAL WELL, PREVENTING BLOOD FROM ENTERING THE SYRINGE AS IT SHOULD AND PROVIDES A CHANCE FOR THE SAMPLE TO BECOME CONTAMINATED WITH AIR. ALL ABG KITS WITH LOT # K107504 WERE PULLED FROM THE CURRENT INVENTORY. RESPIRATORY THERAPIST FOUND AN ABG KIT THAT HAD THE ROUND HUB. THIS KIT WITH THE ROUND HUB WAS USED TO DRAW THE BLOOD SAMPLE. NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX PRO-VENT ARTERIAL BLOOD SAMPLING KIT ABG SAMPLING KIT CBT SIMS PORTEX * K107504

    Patients

    Seq Age Sex Outcome Treatment
    1 * OTHER ABG KITS WITH LOT #K107504