BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 FR S/L POWERPICC FULL TRAY

    MDR report key: 3871771 · Received April 17, 2014

    Report

    Report Number
    3006260740-2014-00191
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 27, 2014
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K091324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF A LEAK IN THE CATHETER WAS CONFIRMED AND THE CAUSE WAS USER-RELATED. THE PRODUCT RETURNED FOR EVAL WAS ONE 4FR S/L POWERPICC TAPE OR DRESSING RESIDUE WAS SEEN ON THE EXTENSION LEG. A SPLIT WAS SEEN AT THE 6CM DEPTH MARKING. AN ATTEMPT TO INFUSE WATER THROUGH THE SAMPLE REVEALED A SPRAYING LEAK AT THE SPLIT SITE. MICROSCOPIC EXAMINATION CONFIRMED A KINK NEAR THE 6CM DEPTH MARKING, AND A CIRCUMFERENTIALLY-ALIGNED SPLIT WAS SEEN ON THE INSIDE EDGE OF THE KINK. THE EDGES OF THE SPLIT WERE SLIGHTLY IRREGULAR, GRANULAR, AND ROUGH. ANOTHER KINK IN THE CATHETER WAS SEEN NEAR THE 8CM DEPTH MARKING BUT NO SPLIT OR HOLES WERE ASSOCIATED WITH THAT KINK. THE CHARACTERISTICS OF THE SPLIT SUGGEST IT WAS CAUSED BY USE-RELATED KINKING OF THE CATHETER. A LOT HISTORY REVIEW (LHR) OF REXL0683 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    LINE WAS PLACED (B)(6) AND PT CAME IN TODAY WITH LEAKING. THE CATHETER HAS A PIN HOLD IN IT AND IT WAS INSIDE THE PT. WE DO PRE-FLUSH OUR CATHETERS BEFORE INSERTION, %CMS OF CATHETER WERE EXTERNAL ON THIS PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236183 4 FR S/L POWERPICC FULL TRAY LJS C.R. BARD, INC. (BASD) REXL0683

    Patients

    Seq Age Sex Outcome Treatment
    1 Other