BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD WHITACRE SPINAL NEEDLE

    MDR report key: 3221440 · Received July 9, 2013

    Report

    Report Number
    2243072-2013-00072
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 6, 2013
    Report Date
    July 9, 2013
    Manufacturer
    BD
    Product Code
    BSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD WAS COMPLETED FOR LOT 2326285 AND ALL INSPECTION WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE NEEDLE BROKE 1.3CM AND STAYED IN THE PT'S BACK DURING SURGERY. ADD'L INFO REC'D VIA TELEPHONE ON (B)(6) 2013, THE REPORTER STATED THAT THE NEEDLE HAS NOT BEEN REMOVED AT THIS TIME. A CT SCAN WAS PERFORMED AND DUE TO ITS LOCATION THE CONSENSUS OF THE TWO SURGEONS WAS AGAINST REMOVAL. CT DID SHOW EXTENSIVE ARTHRITIS SO THEY ARE UNSURE IF IT WAS A TECHNIQUE ISSUE OR ACTUAL DEFECT OF THE PRODUCT. THEY FELT IT MAY HAVE STRUCK A 'CALCIFIED AREA' AND THAT MAY HAVE BEEN THE CAUSE FOR BREAK. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312673 BD WHITACRE SPINAL NEEDLE ANESTHESIA SPINAL BSP BD 2326285

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention