BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPROTTE

    MDR report key: 7005450 · Received November 7, 2017

    Report

    Report Number
    9611612-2017-00013
    Event Type
    Injury
    Date Received
    November 7, 2017
    Report Date
    December 5, 2017
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    BSP
    UDI-DI
    14048223000516
    PMA / PMN Number
    K911202
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON RISK ASSESSMENT AND CLINICAL EVALUATION FILE IS CONSIDERED AS CLOSED.

    Description of Event or Problem · 1

    (B)(4). DATE OF EVENT UNKNOWN. TOOK PLACE IN (B)(6) AND HAS BEEN REPORTED TO TGA. FROM INITIAL REPORTER¿S NARRATIVE: DOCTOR WAS UNAWARE NEEDLE HAD BROKEN OFF, SO CAN'T COMMENT ON WHETHER OCCURRED ON INSERTION OR REMOVAL 4 ATTEMPTS AT LP, 3 NEEDLES USED - 24G X 3 BROKEN-OFF FRAGMENT WAS FOUND WHEN PATIENT RETURNED AS AN OUTPATIENT TO HAVE A FLUOROSCOPIC-GUIDED LP 5 DAYS LATER- IT WAS SEEN ON THE SCOUT FILM. THE PATIENT WAS THEN ADMITTED THROUGH ED AND HAD THE 65MM FRAGMENT REMOVED BY THE NEUROSURGERY TEAM 6 DAYS AFTER THE INITIAL LP. ON THE DAY OF DISCHARGE FROM HOSPITAL THERE HAD BEEN NO ADVERSE OUTCOME RECORDED, ASIDE FROM SURGERY (NO NEUROLOGICAL DEFICIT, NO INFECTION) THE HOSPITAL REPORT IS NOT FINALISED.

    Description of Event or Problem · 1

    IRN# (B)(4). DATE OF EVENT STILL UNKNOWN. TOOK PLACE IN (B)(6) AND HAS BEEN REPORTED TO TGA. FROM INITIAL REPORTER¿S NARRATIVE: DOCTOR WAS UNAWARE NEEDLE HAD BROKEN OFF, SO CAN'T COMMENT ON WHETHER OCCURRED ON INSERTION OR REMOVAL 4 ATTEMPTS AT LP, 3 NEEDLES USED - 24G X 3 BROKEN-OFF FRAGMENT WAS FOUND WHEN PATIENT RETURNED AS AN OUTPATIENT TO HAVE A FLUOROSCOPIC-GUIDED LP 5 DAYS LATER- IT WAS SEEN ON THE SCOUT FILM. THE PATIENT WAS THEN ADMITTED THROUGH ED AND HAD THE 65MM FRAGMENT REMOVED BY THE NEUROSURGERY TEAM 6 DAYS AFTER THE INITIAL LP. ON THE DAY OF DISCHARGE FROM HOSPITAL THERE HAD BEEN NO ADVERSE OUTCOME RECORDED, ASIDE FROM SURGERY (NO NEUROLOGICAL DEFICIT, NO INFECTION) THE HOSPITAL REPORT IS NOT FINALISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787597 SPROTTE SPINAL NEEDLE ANAESTHESIA CONDUCTION BSP PAJUNK GMBH MEDIZINTECHNOLOGIE 041151-30A 1205 14048223000516

    Patients

    Seq Age Sex Outcome Treatment
    1 Other