BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE

    MDR report key: 7526529 · Received May 18, 2018

    Report

    Report Number
    9616656-2018-00105
    Event Type
    Malfunction
    Date Received
    May 18, 2018
    Date of Event
    May 2, 2018
    Report Date
    June 28, 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
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY WITH ADDITIONAL LOT NUMBER, EXPIRATION DATE AND MANUFACTURE DATE INFORMATION: NINETY NINE SEALED 31G X 5MM PEN NEEDLE SAMPLES WERE RETURNED FROM THE FOLLOWING LOT NUMBERS: MEDICAL DEVICE LOT #: 6012737 ¿ ONE SAMPLE WAS RETURNED. MEDICAL DEVICE EXPIRATION DATE: 12/31/2020. DEVICE MANUFACTURE DATE: 01/12/2016. MEDICAL DEVICE LOT #: 6202743 ¿ ONE SAMPLE WAS RETURNED. MEDICAL DEVICE EXPIRATION DATE: 07/31/2021. DEVICE MANUFACTURE DATE: 06/20/2016. MEDICAL DEVICE LOT #: LOT. NO. 7152663 ¿ THREE SAMPLES WERE RETURNED. MEDICAL DEVICE EXPIRATION DATE: 05/31/2022. DEVICE MANUFACTURE DATE: 06/01/2017. MEDICAL DEVICE LOT #: LOT. NO. 6355790 ¿ SIXTEEN SAMPLES WERE RETURNED. MEDICAL DEVICE EXPIRATION DATE: 12/31/2021. DEVICE MANUFACTURE DATE: 12/20/2016. MEDICAL DEVICE LOT #: LOT. NO. 6194830 ¿ FIFTY ONE SAMPLES WERE RETURNED. MEDICAL DEVICE EXPIRATION DATE: 06/30/2021. DEVICE MANUFACTURE DATE: 07/12/2016. MEDICAL DEVICE LOT #: LOT. NO. 7123819 ¿ ELEVEN SAMPLES WERE RETURNED. MEDICAL DEVICE EXPIRATION DATE: 04/30/2022. DEVICE MANUFACTURE DATE: 05/03/2017. MEDICAL DEVICE LOT #: LOT. NO. 7143581 ¿ SIXTEEN SAMPLES WERE RETURNED. MEDICAL DEVICE EXPIRATION DATE: 05/31/2022. DEVICE MANUFACTURE DATE: 05/23/2017. MAGNIFIED EXAMINATION WAS CARRIED OUT ON THIRTY SAMPLES ACROSS ALL LOT NUMBERS AND NO ISSUES WERE OBSERVED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THESE PACKAGED LOTS 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.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. (B)(6). NO LOT # PROVIDED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 NEEDLE OF A BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE BROKE OFF INTO THE THIGH OF A PATIENT. THERE WAS NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370517 BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other