BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE

    MDR report key: 3810192 · Received April 28, 2014

    Report

    Report Number
    9681709-2014-00006
    Event Type
    Other
    Date Received
    April 28, 2014
    Date of Event
    March 14, 2014
    Report Date
    April 7, 2014
    Manufacturer
    UNISIS CORP.
    Product Code
    BSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE WILL SUBMIT THE FOLLOW UP REPORT AS SOON AS WE FINISH INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2014, LUMBAR PUNCTURE WAS CONDUCTED WITH (B)(6) YEARS OLD BOY. SUSPICION: MENINGITIS. DURING PROCEDURE, NEEDLE BENT AND IT WAS DIFFICULT TO REMOVE THE NEEDLE. THE NEEDLE FORMED A BENT ANGLE ABOUT 120 DEGREES. AS IT WAS DIFFICULT TO PULL OUT THE NEEDLE FROM THE SPINAL CANAL, IT IS POSSIBLE THAT DAMAGE OF SURROUNDING TISSUES HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253653 UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE SPINAL NEEDLE BSP UNISIS CORP. 12I041

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR