BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE

    MDR report key: 7907099 · Received September 25, 2018

    Report

    Report Number
    9616656-2018-00208
    Event Type
    Malfunction
    Date Received
    September 25, 2018
    Date of Event
    September 6, 2018
    Report Date
    November 7, 2018
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    OZO
    UDI-DI
    00382903296057
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    TWO PHOTOS WERE RETURNED FROM LOT. NO. 7172622, CAT. NO. 329605. VISUAL EXAMINATION WAS CARRIED OUT AND A BENT CANNULA ATTACHED TO THE PEN INJECTOR WAS OBSERVED ON BOTH PHOTOS. 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. BASED ON THE PHOTOS RETURNED AND THAT NO OFFENDING SAMPLE WAS RETURNED NO ROOT CAUSE CAN BE IDENTIFIED. BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD AUTOSHIELD DUO SAFETY PEN NEEDLE REMAINED FIXED TO THE INSULIN PEN AFTER ENGAGING THE SAFETY MECHANISM. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE REMAINED FIXED TO THE INSULIN PEN AFTER ENGAGING THE SAFETY MECHANISM. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746015 BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE PEN NEEDLE OZO BECTON DICKINSON AND CO. 7172622 00382903296057

    Patients

    Seq Age Sex Outcome Treatment
    1 Other