BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDEPATH, 14.5F

    MDR report key: 3181988 · Received June 17, 2013

    Report

    Report Number
    3006260740-2013-00304
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    MSD
    PMA / PMN Number
    K051748
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER, AT THIS TIME, FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REXD0969 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    CATHETER PLACED ON (B)(6) 2013 - REMOVED ON (B)(6) 2013. DURING REMOVAL CATHETER CAME OUT, BUT NOT THE CUFF. THEY COULD FEEL SOME RESISTANCE WHILE PULLING OUT THE CATHETER, SO THEY LET UP FOR A FEW SECONDS, THEN WHEN THEY DID CONTINUE, OUT CAME THE CATHETER, BUT NO CUFF. THEY COULD FEEL IT UP IN THE TUNNEL TRACT, SO THEY DID RETRIEVE IT USING FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272941 GLIDEPATH, 14.5F MSD C. R. BARD INC. (BASD) REXD0969

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention