BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD WHITACRE SPINAL NEEDLE

    MDR report key: 833100 · Received March 27, 2007

    Report

    Report Number
    2618282-2007-00006
    Event Type
    Injury
    Date Received
    March 27, 2007
    Date of Event
    March 5, 2007
    Report Date
    March 27, 2007
    Manufacturer
    BECTON DICKINSON
    Product Code
    BSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE COMPLAINT DATABASE DID NOT REVEAL ANY OTHER INCIDENTS OF THIS NATURE WITH THESE LOTS OF NEEDLES. THE VAST MAJORITY OF THESE INCIDENTS INVOLVE THE NEEDLE BEING BENT DURING THE PROCEDURE CAUSING THE NEEDLE TO BREAK WHEN RESTRAIGHTENED. OFTEN IF AN INTRODUCER IS USED AND IF THE BENT NEEDLE IS PULLED BACK THROUGH IT, THIS WILL ALSO CAUSE THE NEEDLE TO RESTRAIGHTEN AND BREAK. LOT NUMBER: DEVICE IS FROM ONE OF THE FOLLOWING BULK LOTS: 6081976, 6151842, 6146725, 6130237, 6130242, 6128792, 6164266, 6152061 OR 6159759.

    Description of Event or Problem · 1

    AFTER REPOSITIONING THE NEEDLE MULTIPLE TIMES TO FIND SUBARACHNOID SPACE, THE NEEDLE SNAPPED OFF AT THE HUB. NEEDLE HAD TO BE LOCATED BY X-RAY AND SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD WHITACRE SPINAL NEEDLE 25T 3 1/2 SPINAL NEEDLE, BULK NON-STERILE BSP BECTON DICKINSON NA SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention