BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFSITE NEEDLEFREE SYSTEM ACCESS PIN

    MDR report key: 13872 · Received June 8, 1994

    Report

    Report Number
    MW1002405
    Event Type
    Malfunction
    Date Received
    June 8, 1994
    Date of Event
    April 1, 1994
    Report Date
    May 25, 1994
    Manufacturer
    BURRON MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    "PIN" OF ACCESS PIN DEVICE BROKE OFF DURING ATTEMPT TO INSERT INTO INJECTION PORT OF IV TUBING. (*)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFSITE NEEDLEFREE SYSTEM ACCESS PIN ACCESS PIN FPA BURRON MEDICAL, INC. AP2500 770160

    Patients

    Seq Age Sex Outcome Treatment
    1 *