BEUDAMED
    FDA Adverse Event Summary report: N

    BD INSYTE-N AUTOGUARD WINGED

    MDR report key: 15743821 · Received November 4, 2022

    Report

    Report Number
    MW5113075
    Date Received
    November 4, 2022
    Date of Event
    October 12, 2022
    Report Date
    October 20, 2022
    Manufacturer
    BD
    Product Code
    FOZ
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ATTEMPTED TO START IV X 2 ATTEMPTS WITH INSYTE-N AUTOGUACD WINGED 24 GAUGE X 0.56IN CATHETER (YELLOW PACKAGING, WITH WINGS). HOWEVER, WHEN RN TRIED TO ADVANCE CATHETER, CATHETER TIP "SHREDDED," AND COULD NOT BE ADVANCED. THIS HAPPENED TWICE, AND PER NNP HAS ALSO HAPPENED RECENTLY AT PVH. LOT #2146599. BD, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2334450 BD INSYTE-N AUTOGUARD WINGED CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BD 381511 2146599
    2334451 BD INSYTE-N AUTOGUARD WINGED CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BD 381511 2146599

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Female