BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5 FR DL POWERPICC SOLO WITH TLS, MAXIMAL BARRIER PRECAUTION

    MDR report key: 2052060 · Received March 1, 2011

    Report

    Report Number
    3006260740-2011-00058
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    January 26, 2011
    Report Date
    February 8, 2011
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K053501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS CONFIRMED. AS EVIDENCED BY THE SAMPLE RETURNED IT APPEARS THE GUIDEWIRE HAS BEEN DAMAGED THROUGH USE. THE COMPLAINT SAMPLE RECEIVED SHOWS A KNOT IN THE WIRE THAT IS LOCATED AT THE DISTAL TIP. A BLOOD AND TISSUE RESIDUE IS SEEN ADHERING TO THE WIRE. NO MFG DEFECTS WERE NOTED ON THE WIRE OR THE CATHETER. AT THIS TIME THE MECHANISM OF DAMAGE IS UNDETERMINED. A CHR OF LOT # REUK0503 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    PICC NURSE TRIED ADVANCING THE GUIDEWIRE WHEN IT WOULD NOT ADVANCE ANYMORE. THE NURSE THEN TRIED TO GET THE WIRE OUT AND IT WOULD NOT COME OUT SO SHE NICKED THE PT'S SKIN TO REMOVE IT. PULLED THE WIRE OUT AND NOTICED A KNOT IN WIRE. THE NURSE SAID SHE DID NOT SEE THIS KNOT IN THE WIRE PRIOR TO BEGINNING THE PROCEDURE. SHE BELIEVES THE KNOT WAS COILING AS SHE WAS TRYING TO ADVANCE IT AND THEN KNOTTED WHEN SHE TRIED TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5 FR DL POWERPICC SOLO WITH TLS, MAXIMAL BARRIER PRECAUTION LJS C. R. BARD INC. (BASD) REUK0503

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention