BEUDAMED
    FDA Adverse Event Summary report: N

    MINILOC HUBER PLUS SWIS

    MDR report key: 1081099 · Received July 18, 2008

    Report

    Report Number
    3006260740-2008-00042
    Date Received
    July 18, 2008
    Report Date
    July 11, 2008
    Manufacturer
    C. R. BARD, INC. (BASD)
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL. A CHR REVIEW IS NOT POSSIBLE, AS NO MFG LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    THE COMPLAINANT STATES SHE HAS HAD SEVERAL REPORTS OF INSTANCES WHERE THE NEEDLE (MINILOC HUBER PLUS SWIS) BACKED OUT OF THE PORT CAUSING THE MEDICATION TO INFUSE INTO THE SUBQ TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINILOC HUBER PLUS SWIS INTRAVASCULAR ADMINISTRATION SET FMI C. R. BARD, INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention