BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOWEL OR 17X24IN BLUE 2PK X-RAY DETECTAB

    MDR report key: 10690476 · Received October 16, 2020

    Report

    Report Number
    1423537-2020-00543
    Event Type
    Malfunction
    Date Received
    October 16, 2020
    Date of Event
    September 24, 2020
    Report Date
    October 16, 2020
    Manufacturer
    JIANERKANG MEDICAL DRESSING CO. LTD
    Product Code
    FRL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE DEVICE HISTORY RECORD, LOT NUMBER 190930-15-SH WAS FINISHED ON 10/17/2019. NO EXCEPTION WAS RECORDED IN THE DEVICE HISTORY RECORD THAT COULD LEAD TO THE REPORTED INCIDENT. THE AVERAGE LINTING DATA IS 0.183G / 10 PIECES. THERE IS NO OCCURRENCE REPORTED IN THE PAST 12 MONTHS FOR THIS LOT. NO SAMPLE RETURNED FOR INVESTIGATION, ONLY PHOTOS WERE PROVIDED. THE PICTURE SHOWS LINT ON THE GLOVES. IT LOOKS LIKE WHITE LINT; HOWEVER, THE PRODUCT IS IN BLUE COLOR. FROM THE INVESTIGATION, THERE IS NO ABNORMAL SITUATION WHICH HAPPENED DURING PRODUCTION AND DHR. 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. ACCORDING TO SUPPLIER, OR TOWEL IS MADE OF COTTON, SO COTTON FIBER IS BORN. SUPPLIER 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. (=0.38G/10PIECES). IN THE FOLDING PROCESS, SUPPLIER USED ONE CLOTH PAD UNDER 100PIECES SEMI-FINISHED PRODUCTS TO AVOID LINTING STUCK ONTO THE PRODUCTS DURING PRODUCT'S TRANSFER.

    Description of Event or Problem · 1

    BASED ON INFORMATION FROM THE CUSTOMER THE TOWELS REPORTEDLY LEAVE LINT IN THE STERILE FIELD AND IN THE PATIENT'S BODY. NO INJURY TO PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1159102 TOWEL OR 17X24IN BLUE 2PK X-RAY DETECTAB FIBER, MEDICAL, ABSORBENT FRL JIANERKANG MEDICAL DRESSING CO. LTD 28700-002X 190930-15-SH

    Patients

    Seq Age Sex Outcome Treatment
    1