BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SPINAL NEEDLE

    MDR report key: 1063388 · Received June 19, 2008

    Report

    Report Number
    2618282-2008-00015
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 19, 2008
    Product Code
    BSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PRE-AMEN. ACTUAL SAMPLE NOT RETURNED FOR EVALUATION. THE SAMPLE WOULD NORMALLY BE SENT TO OUR MICROSCOPY LAB FOR SEM ANALYSIS TO DETERMINE THE CAUSE OF THE BREAKAGE. THE VAST MAJORITY OF THESE INCIDENTS INVOLVE THE NEEDLE BEING BENT DURING THE PROCEDURE CAUSING THE NEEDLE TO BREAK WHEN RE-STRAIGHTENING. A REVIEW OF OUR COMPLAINT DATABASE DID NOT REVEAL ANY OTHER INCIDENTS OF THIS NATURE WITH THIS LOT OF PRODUCT. REGULATORY COMPLIANCE WILL CONTINUE TO IDENTIFY ANY CHANGES IN TRENDING.

    Description of Event or Problem · 1

    DURING AN ARTHROGRAM PROCEDURE, NEEDLE BROKE OFF IN PATIENT'S RIGHT SHOULDER. PHYSICIAN UNABLE TO RETRIEVE NEEDLE. PATIENT SENT TO OUTSIDE SURGEON TO RETRIEVE THE NEEDLE - OUTCOME UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD SPINAL NEEDLE 22G X 3 1/2 QUINCKE STERILE SPINAL NEEDLE BSP NA 8016407

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention