BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOWEL OR 17X24IN BLUE STERILE 1/PK

    MDR report key: 10553768 · Received September 18, 2020

    Report

    Report Number
    1423537-2020-00525
    Event Type
    Malfunction
    Date Received
    September 18, 2020
    Date of Event
    August 27, 2020
    Report Date
    September 18, 2020
    Manufacturer
    JIANGSU PROVINCE JIANERKANG MEDICAL
    Product Code
    FRL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE DEVICE HISTORY RECORD, LOT NUMBER 200409-14-SH WAS FINISHED ON 05TH MAY 2020. NO EXCEPTION WAS RECORDED IN THE DEVICE HISTORY RECORD THAT COULD LEAD TO THE REPORTED INCIDENT. THERE IS NO OCCURRENCE REPORTED IN THE PAST 12 MONTHS FOR THIS LOT AND PRODUCT. NO SAMPLE WAS AVAILABLE FOR THIS INVESTIGATION. THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS REPORT. THE COMPLAINT INFORMATION WAS INFORMED TO THE RELEVANT SECTORS FOR THEIR AWARENESS. THERE IS NO ACTION TAKEN AT THIS TIME, HOWEVER, WE 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. (=0.38 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.

    Description of Event or Problem · 1

    BASED ON INFORMATION RECEIVED FROM THE CUSTOMER, THERE WAS REPORTEDLY A CONSIDERABLE AMOUNT OF BLUE LINT BEING INTRODUCED INTO THE OR THEATRE VIA TOWELS. THE PROCEDURE WAS OPEN HEART SURGERY- CORONARY ARTERY BYPASS GRATFS AND THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021891 TOWEL OR 17X24IN BLUE STERILE 1/PK FIBER, MEDICAL, ABSORBENT FRL JIANGSU PROVINCE JIANERKANG MEDICAL 28700-002 200409-14-SH

    Patients

    Seq Age Sex Outcome Treatment
    1