BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPLIT, 14.5 FR, STANDARD KIT, 23 CM, STRAIGHT

    MDR report key: 2971243 · Received February 1, 2013

    Report

    Report Number
    3006260740-2013-00050
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    December 31, 2012
    Report Date
    January 11, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    MSD
    PMA / PMN Number
    K030020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF AN DETACHED CUFF IS INCONCLUSIVE. THE IMAGE IN THE X-RAY REVEALS A CATHETER IN UPPER CHEST CAVITY. THAT IS ALL THAT IS DISCERNIBLE IN THE PICTURE. A CONFIRMATION OF A DISLODGED CATHETER AND DETACHED SURECUFF CANNOT BE CONFIRMED FROM THE PHOTO. AT THIS TIME THE MECHANISM OF DAMAGE IS UNDETERMINED. A LOT HISTORY REVIEW(LHR) OF (B)(4) SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. (421887).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (B)(6) 2012, THE PT WAS IMPLANTED A LONG TERM DIALYSIS CATHETER, THE SURGERY WAS SUCCESSFUL, 3 TIMES ONE WEEK HEMODIALYSIS IN ANOTHER HOSPITAL. ON (B)(6) 2012, THE PT FOUND THE CATHETER OUT OF BODY PART LONGER THAN BEFORE WHEN HE WAS STAY AT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45348 HEMOSPLIT, 14.5 FR, STANDARD KIT, 23 CM, STRAIGHT MSD C. R. BARD INC. (BASD) REVH1266

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention