BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINILOC SHP 20GX.75

    MDR report key: 1277072 · Received December 12, 2008

    Report

    Report Number
    3006260740-2008-00243
    Event Type
    Malfunction
    Date Received
    December 12, 2008
    Date of Event
    August 19, 2008
    Report Date
    December 2, 2008
    Manufacturer
    C. R. BARD, INC. (BASD)
    Product Code
    FPA
    PMA / PMN Number
    K050600
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS INCONCLUSIVE. THE ORIGINAL COMPLAINT SAMPLES WERE NOT RETURNED FOR EVALUATION. ONLY UNOPENED MINILOC SAFETY INFUSION SETS WERE RETURNED FOR EVALUATION. NO DEFECTS RELATED TO THE MANUFACTURING PROCESS WERE NOTED ON THE RETURNED PRODUCTS. THE EXACT CAUSE OF THE REPORTED COMPLAINT IS UNKNOWN. THE PRODUCT IFU INSTRUCTS THE USER TO DRESS AND SECURE SITE PER INSTITUTIONAL PROTOCOL. A CHR OF LOT# D712806 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT. (196860).

    Description of Event or Problem · 1

    DURING TWO ADMINISTRATIONS OF CHEMO THERAPY WITH A PORT SYSTEM THE NEEDLES SLIPPED OUT OF THE SILICON PORT MEMBRANE WITH THE RESULT THAT THE DRUG FLEW OUT. THE USER COMPLAINED THAT THE NEEDLES COULD COME OUT VERY EASY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINILOC SHP 20GX.75 FPA C. R. BARD, INC. (BASD) D712806

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention