BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFESITE ACCESS PIN

    MDR report key: 13064 · Received May 4, 1994

    Report

    Report Number
    MW1001828
    Event Type
    Malfunction
    Date Received
    May 4, 1994
    Date of Event
    April 15, 1994
    Report Date
    April 25, 1994
    Manufacturer
    BURRON MEDICAL, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ACCESS PIN WOULD NOT INSERT INTO INJECTION SITE. NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFESITE ACCESS PIN ACCESS PIN FOZ BURRON MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 *