BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER LOC MAX REF 0142075

    MDR report key: 7697689 · Received July 17, 2018

    Report

    Report Number
    MW5078446
    Event Type
    Malfunction
    Date Received
    July 17, 2018
    Date of Event
    July 13, 2018
    Report Date
    July 13, 2018
    Manufacturer
    C. R. BARD
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    CADD EXTENSION SET FROM SMITHS MEDICAL (B)(4) IS CONNECTED TO POWER LOC MAX REF 142075. THE CONNECTION BETWEEN THESE TWO PRODUCTS HAS ALWAYS BEEN TIGHT, BUT THE LAST FEW MONTHS WE HAVE HAD SEVERAL PTS WHERE THEY HAVE BECOME DISCONNECTED WHILE RECEIVING INFUSIONAL 5FU RESULTING IN A SPLIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536976 POWER LOC MAX REF 0142075 SET, ADMINISTRATION INTRAVASCULAR FPA C. R. BARD
    536977 CADD EXTENSION SET SMITHS MEDICAL REF 21-7047-24 SET, ADMINISTRATION INTRAVASCULAR FPA SMITHS HEALTHCARE MANUFACTURING S. A. DE C. V.

    Patients

    Seq Age Sex Outcome Treatment
    1