BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SDMC CRANIOTOMY PACK (CNKSN)254

    MDR report key: 11174760 · Received January 14, 2021

    Report

    Report Number
    1423537-2021-00587
    Event Type
    Malfunction
    Date Received
    January 14, 2021
    Date of Event
    December 17, 2020
    Report Date
    January 14, 2021
    Manufacturer
    MEX03 MEXICO-JUAREZ PRESOURCE
    Product Code
    OJG
    UDI-DI
    10888439602913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD COULD NOT BE VERIFIED AS LOT NUMBER WAS NOT PROVIDED. THERE IS NO OCCURRENCE REPORTED IN THE PAST 12 MONTHS. NO SAMPLE WAS AVAILABLE FOR INVESTIGATION. ACCORDING TO THE SUPPLIER, THE OR TOWEL IS MADE OF COTTON, SO LINT IS BORN AND INEVITABLE. THE INTENDED USE OF THE OR TOWEL IS USED FOR APPLYING MEDICATION OR ABSORBING SMALL AMOUNTS OF BODY FLUIDS FROM A PATIENT'S BODY SURFACE. SUPPLIER HAS WORKED WITH CARDINAL TO BETTER CONTROL THE LINTING AND HAS IMPLEMENTED SEVERAL MEASURES TO IMPROVE IT: THE SUCTION PROCESS WAS ADDED BEFORE PRODUCTS' FINAL FOLDING AND OPERATORS DO IT ACCORDING TO STANDARD OPERATION PROCEDURE REQUIREMENTS. LINTING TEST METHOD AND ACCEPTABLE CRITERIA WAS STIPULATED TO SEE THE STIPULATED TO SEE THE SUCTION RESULTS (=0.38G/10 PIECES). IN THE FOLDING PROCESS, SUPPLIER USED 1 CLOTH BAG PROTECT 100 PIECES SEMI-FINISHED PRODUCTS TO AVOID LINTING STUCK ONTO THE PRODUCTS DURING PRODUCTS' TRANSFER. FROM THE INVESTIGATION, NO ABNORMAL SITUATION HAPPENED IN PRODUCTION AND ALL LINTING TEST DATA FOR THE PAST 12 MONTHS WAS WITHIN THE ACCEPTABLE RANGE. THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. THERE IS NO ACTION TAKEN AT THIS TIME, BUT SUPPLIER AND CARDINAL WILL CONTINUE TO MONITOR THE TREND OF THIS TYPE OF INCIDENT.

    Description of Event or Problem · 1

    PT REPORTED THAT THE BLUE TOWELS OR-1727BXG FROM THE CRANIOTOMY PACK SNE59CNKSO WERE LINTING AND SOME OF THE LINT GOT INTO THE SURGICAL FIELD DURING A CRANIOTOMY. THE TOWELS WERE USED TO DRAPE THE MAYO STAND. LINT WAS FOUND ON THE BRAIN WHICH WAS REMOVED WITH IRRIGATION AND MANUAL REMOVAL. NO INJURY OR ADVERSE EFFECT WAS REPORTED. PATIENT DEMOGRAPHICS WERE NOT PROVIDED WHEN REQUESTED. REPORT BEING FILED FOR POTENTIAL FOR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65340 SDMC CRANIOTOMY PACK (CNKSN)254 NEUROLOGICAL TRAY OJG MEX03 MEXICO-JUAREZ PRESOURCE SNE59CNKSO UNKNOWN 10888439602913

    Patients

    Seq Age Sex Outcome Treatment
    1 Other