BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AUTOSHIELD¿ DUO PEN NEEDLE

    MDR report key: 16510543 · Received March 9, 2023

    Report

    Report Number
    9616656-2023-00183
    Event Type
    Malfunction
    Date Received
    March 9, 2023
    Date of Event
    February 8, 2023
    Report Date
    June 29, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. THE CUSTOMER RETURNED TWO PHOTOS OF THE 30GX5MM AUTO SHIELD DUO PEN NEEDLE. THE CUSTOMER REPORTED THAT THE NEEDLE BECAME LOGGED IN THE TOP OF THE INSULIN CARTRIDGE DIAPHRAGM. THE PHOTOS WERE EXAMINED AND REVEALS A BROKEN CANNULA STILL ATTACHED TO THE PEN NEEDLE. 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. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BREAKS OFF DURING USE NPE). AS NO PHYSICAL SAMPLES WERE RETURNED FOR INVESTIGATION IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2091864. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2025. DEVICE MANUFACTURE DATE: 01-APR-2022. MEDICAL DEVICE LOT #: 1232944. MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2024. DEVICE MANUFACTURE DATE: 20-AUG-2021. MEDICAL DEVICE LOT #: 2091865. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2025. DEVICE MANUFACTURE DATE: 01-APR-2022.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD AUTOSHIELD¿ DUO PEN NEEDLE BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BD AUTOSHIELD SHARP MALFUNCTIONED, NEEDLE BECAME LOGGED IN THE TOP OF THE INSULIN CARTRIDGE DIAPHRAGM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD AUTOSHIELD¿ DUO PEN NEEDLE BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BD AUTOSHIELD SHARP MALFUNCTIONED, NEEDLE BECAME LOGGED IN THE TOP OF THE INSULIN CARTRIDGE DIAPHRAGM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1630459 BD AUTOSHIELD¿ DUO PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown