BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE

    MDR report key: 8397080 · Received March 6, 2019

    Report

    Report Number
    9616656-2019-00215
    Event Type
    Malfunction
    Date Received
    March 6, 2019
    Date of Event
    February 15, 2019
    Report Date
    March 26, 2019
    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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: 53 SEALED AND INTACT 31G X 8MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 8030906, CAT. NO. 325105. A CLOG TEST WAS CARRIED OUT ON FIFTY 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 PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. NO ISSUES WERE OBSERVED WITH THE RETURNED SAMPLES THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SOME OF THE BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE ARE CLOGGED.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOME OF THE BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE ARE CLOGGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186853 BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. 8030906

    Patients

    Seq Age Sex Outcome Treatment
    1 Other