BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 FR S/L POWERPICC-NURSE BASIC

    MDR report key: 3853682 · Received April 10, 2014

    Report

    Report Number
    3006260740-2014-00168
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Date of Event
    March 16, 2014
    Report Date
    March 16, 2014
    Manufacturer
    C.R. BARD, INC (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K070996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A LOT HISTORY REVIEW (LHR) OF REWF0563 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER HAD BEEN NORMALLY IMPLANTED INTO THE PATIENT FOR A MONTH. WHEN HE HAD INFUSION, THE NURSE FOUND THAT THE CATHETER HAD BEEN BREAKAGE AND LEAKAGE. A NEW DEVICE WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217490 4 FR S/L POWERPICC-NURSE BASIC LJS C.R. BARD, INC (BASD) REWF0563

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention