BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD MICRO-FINE¿ INSULIN PEN NEEDLE 31GX 5MM

    MDR report key: 6185294 · Received December 19, 2016

    Report

    Report Number
    9616656-2016-00081
    Event Type
    Injury
    Date Received
    December 19, 2016
    Date of Event
    December 4, 2016
    Report Date
    December 12, 2016
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K131358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: RESULT - NO PHOTOS OR SAMPLES WERE RETURNED FOR ANALYSIS. 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. CONCLUSION - BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE AS NO SAMPLES WERE RETURNED FOR EVALUATION. WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FOUND THE NEEDLE ON THE SUSPECT DEVICE BROKEN WHEN REMOVED FROM THE SITE. THE PATIENT HAD AN X-RAY BUT THE BROKEN NEEDLE WAS NOT FOUND. THE PATIENT IS REPORTED TO CHANGE THE NEEDLE EVERY TEN DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837520 BD MICRO-FINE¿ INSULIN PEN NEEDLE 31GX 5MM INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 5120482

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention