BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE

    MDR report key: 7269857 · Received February 14, 2018

    Report

    Report Number
    9616656-2018-00019
    Event Type
    Malfunction
    Date Received
    February 14, 2018
    Date of Event
    January 24, 2018
    Report Date
    April 2, 2018
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K110703
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: ONE OPEN 30G X5MM SPN WITHOUT TEARDROP LABEL AND TWO PHOTOS WERE RETURNED FROM LOT. NO. 7040618, CAT. NO. 329705. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED PHOTOS AND SAMPLE AND THERE IS EVIDENCE OF A SEAL ON THE COVER. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED PHOTOS AND SAMPLE AND THERE IS EVIDENCE OF A SEAL ON THE COVER. 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 OR PHOTOS THEREFORE 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.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TEAR DROP LABEL WAS MISSING FROM A BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE. THIS WAS OBSERVED BEFORE USE AND THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114702 BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. 7040618

    Patients

    Seq Age Sex Outcome Treatment
    1 Other