BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE 18GA ANGIOCATHETER AUTOGUARD BC PRO

    MDR report key: 15879123 · Received November 28, 2022

    Report

    Report Number
    MW5113516
    Event Type
    Malfunction
    Date Received
    November 28, 2022
    Date of Event
    November 16, 2022
    Report Date
    November 25, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BD 18GA ANGIOCATHETER STOCKED IN EMS STOREROOM WAS FOUND TO BE CRACKED AT THE OPEN END OF THE HUB, PATIENT WAS STUCK AND THEN BLOOD COULD NOT BE CONTROLLED COMING FROM THE HUB; CRACK WAS IDENTIFIED. PATIENT HAD TO BE STUCK AGAIN. LOT NUMBER 1103755. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2330303 BD INSYTE 18GA ANGIOCATHETER AUTOGUARD BC PRO CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 392644 1103755

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown