BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE AUTOSHIELD DUO 30GX5MM

    MDR report key: 12181017 · Received July 16, 2021

    Report

    Report Number
    9616656-2021-00839
    Event Type
    Malfunction
    Date Received
    July 16, 2021
    Date of Event
    June 7, 2021
    Report Date
    August 19, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K110007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES D.10. RETURNED TO MANUFACTURER ON: 8/10/2021 H.6. INVESTIGATION: THREE SEALED 30G X 5MM AUTOSHIED DUO SAMPLES WERE RETURNED FROM LOT. NO. 1082472, CAT. NO. 329605. AN ACTIVATION TEST 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 AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. NO ISSUES WERE OBSERVED WITH THE RETURNED SAMPLES THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 PEN NEEDLE AUTOSHIELD DUO 30GX5MM EU NEEDLES WERE DIFFICULT TO OPERATE OR HAD SAFETY SHIELD FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CUSTOMER REPORTED THAT IT IS DIFFICULT TO INJECT ALL THE INSULIN BEFORE THE NEEDLE RETRACTS (SOMETIMES TOO QUICKLY) AT THE SLIGHTEST DROP IN PRESSURE DURING INJECTION.

    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 2 PEN NEEDLE AUTOSHIELD DUO 30GX5MM EU NEEDLES WERE DIFFICULT TO OPERATE OR HAD SAFETY SHIELD FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CUSTOMER REPORTED THAT IT IS DIFFICULT TO INJECT ALL THE INSULIN BEFORE THE NEEDLE RETRACTS (SOMETIMES TOO QUICKLY) AT THE SLIGHTEST DROP IN PRESSURE DURING INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1080711 PEN NEEDLE AUTOSHIELD DUO 30GX5MM HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 1082472

    Patients

    Seq Age Sex Outcome Treatment
    1