BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿ INSULIN PEN NEEDLE

    MDR report key: 7252118 · Received February 8, 2018

    Report

    Report Number
    3006948883-2018-00007
    Event Type
    Malfunction
    Date Received
    February 8, 2018
    Date of Event
    January 12, 2018
    Report Date
    April 11, 2018
    Manufacturer
    BD (SUZHOU)
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: ONE SEALED 31G X 5MM PEN NEEDLE SAMPLE WAS RETURNED FROM LOT. NO. 5252281, CAT. NO. 320632. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLE 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 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

    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 DURING USE, A BD MICRO-FINE¿ INSULIN PEN NEEDLE MALFUNCTIONED AS THE NEEDLE BROKE OFF IN THE CUSTOMERS BODY DURING INJECTION OF INSULIN. THERE WAS NO FURTHER REPORT OF INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94016 BD MICRO-FINE¿ INSULIN PEN NEEDLE INSULIN PEN NEEDLE FMI BD (SUZHOU) 5252281

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other