BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOWEL OR 17X24IN BLUE STERILE 4/PK

    MDR report key: 10211637 · Received June 30, 2020

    Report

    Report Number
    1423537-2020-00473
    Event Type
    Malfunction
    Date Received
    June 30, 2020
    Date of Event
    June 8, 2020
    Report Date
    June 30, 2020
    Manufacturer
    JIANERKANG MEDICAL DRESSING CO. LTD.
    Product Code
    FRL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE DEVICE HISTORY RECORD, LOT NUMBER 190812-16-SH WAS MANUFACTURED ON 8/29/2019. NO EXCEPTION WAS RECORDED IN THE DEVICE HISTORY RECORD THAT COULD LEAD TO THE REPORTED INCIDENT. THE AVERAGE LINTING DATA IS 0.210 G / 10 PIECES. NO PHYSICAL SAMPLE WAS PROVIDED; HOWEVER, PHOTOS WERE PROVIDED. BLUE LINT WAS NOTED ON PHOTO. FROM THE INVESTIGATION, THERE IS NO ABNORMAL SITUATION WHICH HAPPENED DURING 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, HOWEVER, THE 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. (=0.38 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

    CATH LAB IS REPORTEDLY EXPERIENCING BLUE LINT COMING OFF THE BLUE OR TOWELS. IT IS A SINGLE STERILE TOWEL PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679456 TOWEL OR 17X24IN BLUE STERILE 4/PK FIBER, MEDICAL, ABSORBENT FRL JIANERKANG MEDICAL DRESSING CO. LTD. 28700-004 190812-16-SH

    Patients

    Seq Age Sex Outcome Treatment
    1