BEUDAMED
    FDA Adverse Event Death Summary report: N

    VAS-CATH NIAGARA KIT 13.5 F X 15 CM [SHORT TERM DUAL-LUM

    MDR report key: 3062767 · Received April 12, 2013

    Report

    Report Number
    3006260740-2013-00156
    Event Type
    Death
    Date Received
    April 12, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    MPB
    PMA / PMN Number
    K030268
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF A DISLODGED CATHETER IS CONFIRMED. AT THIS TIME THE MECHANISM AS TO HOW THE CATHETER DISLODGED FROM THE PT IS UNDETERMINED. ACCORDING TO THE E-MAIL THAT HAS BEEN SENT BY THE FACILITY HERLEV CENTRALSYGEHUS HOSPITAL. A PHOTOGRAPH WAS TAKEN OF THE ALLEGED COMPLAINT SAMPLE AND PATIENT. THE IMAGE IN THE PICTURE REVEALS THE CATHETER HAS SEPARATED FROM THE ANCHORED ATTACHABLE SUTURE WING. THE GREEN ROTATABLE FIXED SUTURE WING SHOWS NO INDICATIONS OF SUTURE ANCHORING. THE TWO SUTURE ORIENTATION HOLES ARE UNREMARKABLE. THE PRODUCT INSTRUCTIONS FOR USE STATE, "THE ROTATABLE, PRE-ATTACHED SUTURE WING IS ORIENTED TO THE SKIN SURFACE AND THE CATHETER IS ATTACHED USING EITHER A STATLOCK STABILIZATION DEVICE OR SUTURE." A LOT HISTORY REVIEW (LHR) IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER INFO HAS BEEN PROVIDED BY THE COMPLAINT.

    Description of Event or Problem · 1

    THE DIALYSIS CATHETER SEPARATED WHILE THE PT WAS ASLEEP. THE PT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157704 VAS-CATH NIAGARA KIT 13.5 F X 15 CM [SHORT TERM DUAL-LUM MPB C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death