BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD AUTOSHIELD¿ DUO PEN NEEDLE

    MDR report key: 8219501 · Received January 4, 2019

    Report

    Report Number
    9616656-2018-00372
    Event Type
    Injury
    Date Received
    January 4, 2019
    Date of Event
    December 13, 2018
    Report Date
    January 23, 2019
    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
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES OR PHOTOS WERE RETURNED FOR ANALYSIS. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCE'S WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER USE OF THE BD AUTOSHIELD¿ DUO PEN NEEDLE WHEN A QUT STUDENT WAS DISPOSING OF THE SHARPS HE WAS STUCK BY A NEEDLE.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER USE OF THE BD AUTOSHIELD DUO PEN NEEDLE WHEN A QUT STUDENT WAS DISPOSING OF THE SHARPS HE WAS STUCK BY A NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11391 BD AUTOSHIELD¿ DUO PEN NEEDLE NEEDLE FMI BECTON DICKINSON AND CO. 8138950

    Patients

    Seq Age Sex Outcome Treatment
    1 Other