BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE

    MDR report key: 8294765 · Received January 31, 2019

    Report

    Report Number
    9616656-2019-00121
    Event Type
    Malfunction
    Date Received
    January 31, 2019
    Date of Event
    January 2, 2019
    Report Date
    February 1, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K131358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIRTY ONE SEALED AND ONE OPEN 31G X 8MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 8072788, CAT. NO. 325105. VISUAL EXAMINATION WAS CARRIED OUT ON THE OPEN SAMPLE AND BURN MARKS WERE OBSERVED ON THE COVER. VISUAL EXAMINATION WAS ALSO CARRIED OUT ON THE THIRTY ONE SEALED 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. THE MOST LIKELY CAUSE OF THIS ISSUE IS INCORRECT MOULDING MACHINE START-UP.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THAT BEFORE USE OF THE BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE AT THE OPENING THE PACKAGE BY THE NURSE, IT WAS DETERMINED THAT A CANNULA IS EXTERNALLY CONTAMINATED.

    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 WITH THAT BEFORE USE OF THE BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE AT THE OPENING THE PACKAGE BY THE NURSE, IT WAS DETERMINED THAT A CANNULA IS EXTERNALLY CONTAMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86838 BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. 8072788

    Patients

    Seq Age Sex Outcome Treatment
    1 Other