BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETRO LONG-TERM HEMODIALYSIS CATHETER 16F FULL PROCEDURE T

    MDR report key: 3802362 · Received February 21, 2014

    Report

    Report Number
    3006260740-2014-00071
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 30, 2014
    Manufacturer
    C.R. BARD, INC. (BARD)
    Product Code
    MSD
    PMA / PMN Number
    K022644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF A BREAK IN THE VENOUS EXTENSION TUBING IS INCONCLUSIVE. THE IMAGES IN THE PHOTOS SHOW A RED ARTERIAL EXTENSION LEG. THE COMPRESSION CLAMP IS ENGAGED AND IS LOCKED ONTO THE EXTENSION TUBING. THE CATHETER HAS SEPARATED DISTAL TO THE PRINTED LOGO. NO OBVIOUS DAMAGE TO THE EXTENSION TUBING CAN BE DISCERNED FROM THE PHOTO. IF THE COMPLAINT SAMPLE IS RETURNED REGARDING THIS INCIDENT, THE INVESTIGATION WILL BE READDRESSED. A LOT HISTORY REVIEW (LHR) OF ASWC001 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. BOTH COMPLAINTS FOR THIS LOT NUMBER (ASWC0001) HAVE BEEN REPORTED FROM ONE (B)(6) FACILITY.

    Description of Event or Problem · 1

    THE RED CONNECTOR WAS CRACKED DURING TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110319 RETRO LONG-TERM HEMODIALYSIS CATHETER 16F FULL PROCEDURE T CATHETER, HEMODIALYSIS, IMPLANTED MSD C.R. BARD, INC. (BARD) ASWC0001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention