BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT, NEURO (JEGI )679

    MDR report key: 10399263 · Received August 12, 2020

    Report

    Report Number
    1423537-2020-00497
    Event Type
    Malfunction
    Date Received
    August 12, 2020
    Date of Event
    July 16, 2020
    Report Date
    August 12, 2020
    Manufacturer
    TX134 TX-EL PASO-DON HASKINS
    Product Code
    OJG
    UDI-DI
    10888439428698
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS RETURNED FOR INVESTIGATION. THE SUPPLIER STATED THEY COULD NOT REVIEW THE DEVICE HISTORY RECORD DURING THEIR INVESTIGATION BECAUSE THE LOT NUMBER WAS NOT PROVIDED. HOWEVER, SUPPLIER REVIEWED THEIR RECORDS FOR THE LAST 2 YEARS AND DID NOT FIND ANYTHING ABNORMAL. ACCORDING TO THE 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: 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. (=0.38 G/10 PIECES). 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 SHARED WITH THE RELEVANT SECTORS FOR THEIR AWARENESS. THERE IS 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 REPORTED LINTING WAS DISCOVERED WHILE THE SURGEON WAS DRYING HIS HANDS AFTER SCRUBBING FOR A NEUROSURGERY. NO INJURY OR DELAY NOTED. THE SAMPLE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864148 KIT, NEURO (JEGI )679 NEUROLOGICAL TRAY OJG TX134 TX-EL PASO-DON HASKINS PN21NJEGJ UNKNOWN 10888439428698

    Patients

    Seq Age Sex Outcome Treatment
    1