BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AUTOSHIELD¿ DUO PEN NEEDLE

    MDR report key: 14496169 · Received May 25, 2022

    Report

    Report Number
    9610847-2022-00194
    Event Type
    Malfunction
    Date Received
    May 25, 2022
    Date of Event
    April 20, 2022
    Report Date
    June 1, 2022
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMI
    PMA / PMN Number
    K110703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT HAS BEEN IDENTIFIED AS A DUPLICATE OF MFR REPORT #: 9610847-2022-00179. THIS COMPLAINT IS THEREFORE BEING CANCELLED, AND MAY BE DISREGARDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD AUTOSHIELD¿ DUO PEN NEEDLE WAS DIFFICULT TO OPERATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DC- VERBATIM: 000954367, 2021-05-25 BD AUTOSHIELD DUO PEN NEEDLE 564014 329508 370004, 2021-05-25."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD AUTOSHIELD¿ DUO PEN NEEDLE WAS DIFFICULT TO OPERATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DC- VERBATIM: 000954367 2021-05-25 BD AUTOSHIELD DUO PEN NEEDLE 564014 329508 370004 2021-05-25".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1878323 BD AUTOSHIELD¿ DUO PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown