BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERGOSHONG CATH 5F FT (SL) (45CM)

    MDR report key: 3810803 · Received March 21, 2014

    Report

    Report Number
    3006260740-2014-00134
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Report Date
    February 27, 2014
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K063848
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER, AT THIS TIME, FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REWF0901 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE IS FLUID LEAKING FROM THE EXIT SITE. A KNOWN VESICANT HAS BEEN PLACED INSIDE THE POWERPICC. POWERPICC IS CURRENTLY INSITU WITH A PLAN TO REMOVE AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169666 POWERGOSHONG CATH 5F FT (SL) (45CM) CATHETER INTRAVASCULAR, THERAPEUTIC LONG-TERM LJS C.R. BARD, INC. (BASD) REWF0091

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention