BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE

    MDR report key: 7931913 · Received October 3, 2018

    Report

    Report Number
    9616656-2018-00227
    Event Type
    Malfunction
    Date Received
    October 3, 2018
    Date of Event
    September 12, 2018
    Report Date
    October 16, 2018
    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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TWO OPENED 30G X 5MM SAFETY PEN NEEDLE CARTONS CONTAINING SEALED SAMPLES WERE RETURNED FROM LOT. NO. 8081871, CAT. NO. 329605. VISUAL EXAMINATION WAS CARRIED OUT ON ALL RETURNED SAMPLES AND NO ISSUES WERE OBSERVED WITH THE TEARDROP LABELS. ALL SAMPLES HAD A TEARDROP LABEL PRESENT. 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. 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 BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE HAD PACKAGING FAILURE WHICH LED TO A BREACH IN THE STERILE BARRIER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    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 HAD PACKAGING FAILURE WHICH LED TO A BREACH IN THE STERILE BARRIER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773751 BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. 8081871

    Patients

    Seq Age Sex Outcome Treatment
    1 Other