BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ULTRA-FINE INSULIN PEN NEEDLE

    MDR report key: 5007799 · Received August 12, 2015

    Report

    Report Number
    9616656-2015-00001
    Event Type
    Injury
    Date Received
    August 12, 2015
    Report Date
    August 12, 2015
    Manufacturer
    B D
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A BD ULTRA-FINE INSULIN NEEDLE W/A NOVOLOG FLEXPEN, THE NEEDLE BROKE OFF IN THE CONSUMER'S ARM BECAUSE THE PEN WAS NOT DEPRESSING CORRECTLY AS THERE WAS A PISTON ROD FLOATING IN THE DEVICE. THE CONSUMER WAS EVALUATED IN AN EMERGENCY DEPT WHERE HE RECEIVED AN X-RAY WHICH DID NOT LOCATE THE BROKEN NEEDLE. HE WAS ADVISED THAT THE INJECTION SITE LOOKED FINE, THAT THE NEEDLE WOULD WORK ITS WAY OUT ON ITS OWN, AND WAS PRESCRIBED AN UNKNOWN ORAL ANTIBIOTIC FOR PROPHYLAXIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531319 BD ULTRA-FINE INSULIN PEN NEEDLE INSULIN PEN NEEDLE FMI B D UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention