BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD K

    MDR report key: 3831909 · Received March 6, 2014

    Report

    Report Number
    3006260740-2014-00093
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    February 9, 2014
    Report Date
    February 10, 2014
    Manufacturer
    C.R. BARD, INC (BASD)
    Product Code
    MSD
    PMA / PMN Number
    K051748
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    A PHOTOGRAPH WAS SUBMITTED FOR REVIEW WHICH CONCERNED A DETACHED CUFF. THE PHOTO APPEARED TO SHOW THE REGION OF CATHETER WHICH SHOULD HAVE INCLUDED A CUFF. THE INDENTATIONS TYPICALLY SEEN FROM A REMOVED CUFF WERE SEEN IN THIS BAND. NO OTHER INFO COULD BE GATHERED FROM THE PHOTOGRAPH. THE COMPLAINT OF A DETACHED CUFF WAS CONFIRMED, BUT THE CAUSE IS UNK. A LOT HISTORY REVIEW (LHR) OF REVK0143 SHOWED TWO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS MANUFACTURER. BOTH COMPLAINTS FOR THIS LOT NUMBER (REVK0143) HAVE BEEN REPORTED FROM ONE CANADA FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON PLANNED REMOVAL OF CATHETER, CUFF PULLED OFF CATHETER AND REMAINED IN THE, LEFT SIDE, CHEST WALL OF THE PT. THE CUFF WAS SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134542 HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD K MSD C.R. BARD, INC (BASD) REVK0143

    Patients

    Seq Age Sex Outcome Treatment
    1