BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IR NEURO PACK 629

    MDR report key: 10102513 · Received May 29, 2020

    Report

    Report Number
    1423537-2020-00462
    Event Type
    Malfunction
    Date Received
    May 29, 2020
    Date of Event
    April 29, 2020
    Report Date
    June 5, 2020
    Manufacturer
    MEX03 MEXICO-JUAREZ PRESOURCE
    Product Code
    OJG
    UDI-DI
    10888439390407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT IS BEING FILED SINCE THE RESULTS OF INVESTIGATION ARE AVAILABLE. FROM THE DEVICE HISTORY RECORD, LOT#20191112-23-SH WAS MANUFACTURED ON 15TH NOV 2019. NO EXCEPTION WAS RECORDED IN THE DEVICE HISTORY RECORD THAT COULD LEAD TO THE REPORTED INCIDENT. SUPPLIER REVIEWED RECORDS OVER THE LAST 2 YEARS, AND NO ABNORMAL SITUATION WAS FOUND. A SAMPLE WAS NOT RETURNED AT THE TIME OF THE INVESTIGATION BUT A PHOTO OF LINT WAS PROVIDED FOR REVIEW. ACCORDING TO SUPPLIER, OR TOWEL IS MADE OF COTTON, SO COTTON FIBER IS A NATURAL CHARACTERISTIC. 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. (=0.38G/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 HAPPENED 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 SUPPLIER WILL CONTINUE TO MONITOR THE TREND OF THIS TYPE OF INCIDENT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS FORWARDED TO THE MANUFACTURING FACILITY WHERE IT IS CURRENTLY STILL UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE THE RESULTS HAVE BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE BLUE, STERILE, COTTON OR TOWELS PWTB04-STM, FROM THE IR NEURO PACK SAN44IRUTA/LOT 375598 ARE SHEDDING FIBERS ONTO VARIOUS WIRES AND CATHETERS DURING A INTRACRANIAL EMBOLIZATION. THE TOWELS WERE USED FOR FLUID ABSORPTION OUTSIDE THE DRAPE. THERE WAS NO INJURY OR DELAY. NO PATIENT DEMOGRAPHICS WERE PROVIDED AFTER ATTEMPTS. CARDINAL HEALTH IS PROACTIVELY FILING A REPORT FOR MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563637 IR NEURO PACK 629 NEUROLOGICAL TRAY OJG MEX03 MEXICO-JUAREZ PRESOURCE SAN44IRUTA 375598 10888439390407

    Patients

    Seq Age Sex Outcome Treatment
    1 Other