BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRANIOTOMY PACK (CNKDC)692

    MDR report key: 10299197 · Received July 20, 2020

    Report

    Report Number
    1423537-2020-00486
    Event Type
    Malfunction
    Date Received
    July 20, 2020
    Date of Event
    June 24, 2020
    Report Date
    July 20, 2020
    Manufacturer
    MEX03 MEXICO-JUAREZ PRESOURCE
    Product Code
    OJG
    UDI-DI
    10888439466560
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE SUPPLIER¿S INVESTIGATION, DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. HOWEVER, THE SUPPLIER REVIEWED THE RECORDS IN THE LAST TWO YEARS AND NO ABNORMAL SITUATION WAS FOUND. NO SAMPLE WAS AVAILABLE AT THE TIME OF THE INVESTIGATION. ACCORDING TO SUPPLIER, OR TOWEL IS MADE OF COTTON, SO COTTON FIBER IS BORN. THE SUPPLIER IS CONTINUOUSLY WORKING WITH CARDINAL HEALTH TO BETTER CONTROL THE LINTING AND HAVE IMPLEMENTED SEVERAL MEASURES TO IMPROVE IT: A. SUCTIONS MACHINES HAVE BEEN INSTALLED IN GREY CLOTH ROLLING PROCESS, DYEING PROCESS AND CUTTING PROCESS. B. THE SUCTION PROCESS WAS ADDED BEFORE PRODUCT'S FINAL FOLDING, AND WORKERS DO IT ACCORDING TO STANDARD OPERATION PROCEDURE REQUIREMENT. C. LINTING TEST METHOD AND ACCEPTABLE CRITERIA WAS STIPULATED TO SEE THE SUCTION RESULTS. (=0.38 G/10 PIECES). D. IN THE FOLDING PROCESS, SUPPLIER USED ONE CLOTH PAD UNDER 100 PIECES SEMI-FINISHED PRODUCTS TO AVOID LINTING STUCK ONTO THE PRODUCTS DURING PRODUCT'S TRANSFER. FROM THE INVESTIGATION, NO ABNORMAL SITUATION OCCURRED DURING PRODUCTION AND THE SAMPLE WAS NOT AVAILABLE; THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT INFORMATION WAS SHARED WITH THE RELEVANT SECTORS FOR THEIR AWARENESS. NO ACTION TAKEN AT THIS TIME, BUT THE SUPPLIER WILL CONTINUE TO MONITOR TRENDS FOR THIS TYPE OF INCIDENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTS TOO MUCH LINT COMING OFF OF THE TOWELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764134 CRANIOTOMY PACK (CNKDC)692 NEUROLOGICAL TRAY OJG MEX03 MEXICO-JUAREZ PRESOURCE SNE69CNKDD UNKNOWN 10888439466560

    Patients

    Seq Age Sex Outcome Treatment
    1