BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFSITE ACCESS PIN

    MDR report key: 10954 · Received January 18, 1994

    Report

    Report Number
    MW1000406
    Event Type
    Malfunction
    Date Received
    January 18, 1994
    Date of Event
    January 6, 1994
    Report Date
    January 6, 1994
    Manufacturer
    BURRON MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UNABLE TO PUNCTURE RUBBER ACCESS PORT WITH PIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFSITE ACCESS PIN FPA BURRON MEDICAL, INC. AP-2500 704610

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other