BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE

    MDR report key: 3810268 · Received April 28, 2014

    Report

    Report Number
    9681709-2014-00005
    Event Type
    Other
    Date Received
    April 28, 2014
    Date of Event
    January 17, 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) GIRL. SUSPICION: NEUROBORRELIOSIS. DURING PROCEDURE, NEEDLE BENT AND CAUSED PROBLEMS IN COLLECTING CSF FOR FURTHER STUDIES. DIFFICULT TO PUT IN OF THE NEEDLE UNDER APPROPRIATE ANGLE WHICH CAUSED ADD'L PUNCTURE OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253723 UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE SPINAL NEEDLE BSP UNISIS CORP. 13B015

    Patients

    Seq Age Sex Outcome Treatment
    1 5.5 YR