BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOCATH-N, AUTOGUARD

    MDR report key: 1233008 · Received November 10, 2008

    Report

    Report Number
    1233008
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    August 28, 2008
    Report Date
    November 6, 2008
    Manufacturer
    BD INFUSION THERAPY SYSTEMS, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    RN IN PEDIATRIC ICU REPORTED A PROBLEM WITH THE BD ANGIOCATH-N AUTOGUARD. STATED THAT WHEN SHE WAS ATTEMPTING TO RESTART IV, THE ANGIOCATH INSERTED AND THE SPRING WOULDN'T WORK AND NEEDLE WOULDN'T RETRACT. ALSO HAD DIFFICULTIES WITH THE ANGIOCATH "SPLITTING" AND THE TIP "SHREDDING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOCATH-N, AUTOGUARD CATHETER, IV FOZ BD INFUSION THERAPY SYSTEMS, INC. * 8009372

    Patients

    Seq Age Sex Outcome Treatment
    1 *