BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURO CRANI (CNQEC)308

    MDR report key: 10852003 · Received November 17, 2020

    Report

    Report Number
    1423537-2020-00560
    Event Type
    Malfunction
    Date Received
    November 17, 2020
    Date of Event
    October 21, 2020
    Report Date
    November 17, 2020
    Manufacturer
    MEX03 MEXICO-JUAREZ PRESOURCE
    Product Code
    OJG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON SUPPLIER INVESTIGATION, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS A LOT NUMBER WAS NOT PROVIDED. SUPPLIER REVIEWED RECORDS OVER THE LAST 2 YEARS AND NO ABNORMAL SITUATION WAS FOUND. THERE ARE 182 OCCURRENCES REPORTED IN THE PAST 12 MONTHS. NO SAMPLE WAS AVAILABLE FOR INVESTIGATION, BUT A PHOTO WAS PROVIDED. THE PHOTO SHOWED LINT ON THE HANDS OF THE STAFF MEMBER. ACCORDING TO THE SUPPLIER, THE OR TOWEL IS MADE OF COTTON, SO COTTON FIBER IS BORN. SUPPLIER IS CONTINUOUSLY WORKING WITH CARDINAL HEALTH TO BETTER CONTROL THE LINTING AND HAVE IMPLEMENTED SEVERAL MEASURES TO IMPROVE IT: SUCTIONS MACHINES HAVE BEEN INSTALLED IN GREY CLOTH ROLLING PROCESS, DYEING PROCESS AND CUTTING PROCESS. THE SUCTION PROCESS WAS ADDED BEFORE PRODUCT'S FINAL FOLDING, AND WORKERS DO IT ACCORDING TO STANDARD OPERATION PROCEDURE REQUIREMENT. LINTING TEST METHOD AND ACCEPTABLE CRITERIA WAS STIPULATED TO SEE THE SUCTION RESULTS. (B)(4). IN THE FOLDING PROCESS, SUPPLIER USED ONE CLOTH PAD UNDER (B)(4) SEMI-FINISHED PRODUCTS TO AVOID LINTING STUCK ONTO THE PRODUCTS DURING PRODUCT'S TRANSFER. FROM THE INVESTIGATION, THERE IS NO ABNORMAL SITUATION THAT HAS OCCURRED IN PRODUCTION. THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT INFORMATION WAS INFORMED TO THE RELEVANT SECTORS FOR THEIR AWARENESS. THERE IS NO ACTION TAKEN AT THIS TIME, BUT THE SUPPLIER WILL CONTINUE TO MONITOR THE TREND OF THIS TYPE OF INCIDENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A LARGE AMOUNT OF LINT ON THE BLUE TOWELS PWTB04-STM FROM THE NEURO CRANIOTOMY KIT SNE30CNQED. NO INJURY WAS REPORTED. NO CLINICAL DATA OR PATIENT DEMOGRAPHICS (HEIGHT, WEIGHT, AGE, SEX) WERE PROVIDED AFTER NUMEROUS ATTEMPTS TO OBTAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322721 NEURO CRANI (CNQEC)308 NEUROLOGICAL TRAY OJG MEX03 MEXICO-JUAREZ PRESOURCE SNE30CNQED UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1