BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD¿ INSULIN PEN NEEDLE

    MDR report key: 7359158 · Received March 21, 2018

    Report

    Report Number
    9616656-2018-00068
    Event Type
    Injury
    Date Received
    March 21, 2018
    Date of Event
    March 12, 2018
    Report Date
    May 4, 2018
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K131358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THREE SEALED 31G X 5MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 7200545, CAT. NO. (B)(4). VISUAL EXAMINATION 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. INVESTIGATION CONCLUSION: NO ISSUES WERE OBSERVED WITH THE RETURNED SAMPLES THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING USE OF THE BD¿ INSULIN PEN NEEDLE THE CONSUMER EXPERIENCED A NEEDLE BREAK WITH INTERVENTION. IT WAS STATED THE ¿NEEDLE BROKE DURING INJECTION. NEEDLE REMAINED IN PATIENT'S BODY. HOSPITAL TRIED TO LOCATE NEEDLE, BUT COULD NOT. NO SURGERY.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200908 BD¿ INSULIN PEN NEEDLE INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 7200545

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention