BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PEN NEEDLE

    MDR report key: 2757736 · Received September 19, 2012

    Report

    Report Number
    9616656-2012-00033
    Event Type
    Injury
    Date Received
    September 19, 2012
    Date of Event
    August 22, 2012
    Report Date
    September 19, 2012
    Manufacturer
    BD
    Product Code
    FMI
    PMA / PMN Number
    K051899
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: CUSTOMER RETURNED (54) SEALED 5MM X 31G PEN NEEDLES FROM LOT # 1062511. THIRTY OUT OF 54 RETURNED SAMPLES WERE EXAMINED AND NO BENT, BROKEN, OR DETACHED PT END OR NON PT END OF THE CANNULA WAS OBSERVED. SINCE THE SAMPLE INVOLVED IN THE INCIDENT WAS NOT RETURNED BY THE CUSTOMER, COMPLAINT CANNOT BE CONFIRMED AS A DEFECT. COMPLAINT HISTORY CHECK YIELDED NO OTHER COMPLAINTS FOR SIMILAR CONDITION FOR THE LOT REPORTED. DEVICE HISTORY REVIEW WAS CONDUCTED AND NO ANOMALIES NOTED. QUALITY WILL CONTINUE TO MONITOR ON MONTHLY TREND REPORTS.

    Description of Event or Problem · 1

    CONSUMER HAD A NEEDLE BREAK OFF. HE WENT TO EMERGENCY ROOM AND HAD AN X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD PEN NEEDLE 31G X 5MM PEN NEEDLE FMI BD 1062511

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention