BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERGLIDE MIDLINE CATHETER, 20G 10CM

    MDR report key: 3874617 · Received April 24, 2014

    Report

    Report Number
    3006260740-2014-00204
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Report Date
    April 3, 2014
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    FOZ
    PMA / PMN Number
    K121073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION, AS THE DEVICE WAS DISCARDED AFTER THE EVENT OCCURRED.

    Description of Event or Problem · 1

    DURING INSERTION, THE CATHETER HAD WOUND BACK UPON ITSELF. NO BLOOD DRAW WAS ACHIEVED AND PRODUCT WAS REMOVED FROM PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248153 POWERGLIDE MIDLINE CATHETER, 20G 10CM FOZ C.R. BARD, INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention