BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ORIGINAL PEN NEEDLE

    MDR report key: 2937978 · Received January 25, 2013

    Report

    Report Number
    9616656-2013-00006
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    December 17, 2012
    Report Date
    January 25, 2013
    Manufacturer
    BD
    Product Code
    FMI
    PMA / PMN Number
    K051899
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURN IS ANTICIPATED. COMPLIANT HISTORY CHECK YIELDED ONE OTHER COMPLAINT FOR SIMILAR CONDITION FOR THE LOT # 8183249. DATE IS FOR LOT # 8107570. THERE WERE NO OTHER COMPLAINTS FOR SIMILAR CONDITION FOR LOT # 8107570. DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT # 8183249 AND NO ANOMALIES NOTED. DHR REVIEW FOR LOT # 8107570 IS BEING CONDUCTED. QUALITY WILL CONTINUE TO MONITOR ON MONTHLY TREND REPORTS.

    Description of Event or Problem · 1

    CONSUMER HAD A PEN NEEDLE BROKE OFF IN ABDOMEN ON (B)(6) 2012. CONSUMER HAD ULTRASOUND AND X-RAY AT THE HOSPITAL. NEEDLE WAS LOCATED ON ULTRA SOUND AND X-RAY, BUT NOT FOUND UPON REMOVAL ATTEMPT. CUSTOMER SUSPECTS PEN NEEDLE LOT IS EITHER 8183249 OR 8107570. CUSTOMER COULD NOT SPECIFY WHICH LOT NUMBER WAS INVOLVED IN THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36333 BD ORIGINAL PEN NEEDLE 12.7MM X 29G PEN NEEDLE FMI BD 8183249

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention