BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HICKMAN HEMODIALYSIS / APHERESIS 13.5 FR ROUND D/L CATHETER

    MDR report key: 3061632 · Received April 11, 2013

    Report

    Report Number
    3006260740-2013-00155
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 22, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K830233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT OF A BREAK IN THE CATHETER IS CONFIRMED AND WILL BE REPORTED AS USER RELATED. A COMPLETE BREAK IN THE CATHETER WAS OBSERVED AT THE VENOUS STAGGERED TIP. THERE IS NO EVIDENCE OF ANY MFG RELATED DAMAGE OR DEFECT. THE CHARACTERISTICS OF THE DAMAGE FOUND AT THE STAGGERED VENOUS TRANSITION SITE IS CONSISTENT WITH A TENSILE BREAK. IT APPEARS THE CATHETER HAS BEEN STRETCHED BEYOND ITS ELASTIC LIMITS. THE COMPLAINANT INDICATES DURING THE PLACEMENT PROCEDURE, "THE USER FOUND THE CATHETER TIP BREAKAGE." THIS WOULD COLLABORATE WITH THE FINDINGS IDENTIFIED WITH THE COMPLAINT SAMPLE. THIS MAY BE A USER TECHNIQUE ISSUE. THE BROKEN VENOUS STAGGERED TIP WAS NOT RETURNED FOR EVAL. A LOT HISTORY REVIEW (LHR) OF REWD1651 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING HICKMAN PLACEMENT, THE USER FOUND THE CATHETER TIP BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157232 HICKMAN HEMODIALYSIS / APHERESIS 13.5 FR ROUND D/L CATHETER LJS C. R. BARD INC. (BASD) REWD1651

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention