BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER LOCK

    MDR report key: 3963546 · Received July 24, 2014

    Report

    Report Number
    MW5037460
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 1, 2014
    Report Date
    July 24, 2014
    Manufacturer
    BARD
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BARD POWER LOCK PORTA CATH ACCESS NEEDLE LEAKS BLOOD FROM NEEDLE AND TUBING INADVERTENTLY DISCONNECTS FROM LUER HUB. THIS HAS BEEN NOTED IN MULTIPLE LOT NUMBERS BUT NOT ALL SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434892 POWER LOCK PORT CATH ACCESS NEEDLE FMI BARD ASYCS104

    Patients

    Seq Age Sex Outcome Treatment
    1