BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AUTOSHIELD DUO SAFETY PEN NEEDLE

    MDR report key: 9635887 · Received January 28, 2020

    Report

    Report Number
    9616656-2020-00039
    Event Type
    Malfunction
    Date Received
    January 28, 2020
    Date of Event
    January 7, 2020
    Report Date
    February 26, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWO OPEN 30G X 5MM SAFETY PEN NEEDLE SAMPLES WERE RETURNED FROM LOT NO. 9141984, CAT. NO. 329605 ALONG WITH ONE OPEN 30G X 5MM SAFETY PEN NEEDLE SAMPLE FROM LOT NO. 9051755, CAT. NO. 329605. A CLOG TEST AS PER TP700483 WAS CARRIED OUT ON ALL THREE SAMPLES AND NO ISSUES WERE OBSERVED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. NO ISSUES WERE OBSERVED WITH THE RETURNED SAMPLES THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE WAS CLOGGED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT: PROBLEMS WITH ACCESSIBILITY, THE NEEDLE HAS BEEN SAVED, CLOGGED NEEDLES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE WAS CLOGGED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT: PROBLEMS WITH ACCESSIBILITY, THE NEEDLE HAS BEEN SAVED, CLOGGED NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103232 BD AUTOSHIELD DUO SAFETY PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. 9051755

    Patients

    Seq Age Sex Outcome Treatment
    1 Other