BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOWEL OR BLUE STERILE

    MDR report key: 14739144 · Received June 17, 2022

    Report

    Report Number
    1423537-2022-00792
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    May 18, 2022
    Report Date
    June 17, 2022
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    FRL
    UDI-DI
    10630140917257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON SUPPLIER INVESTIGATION, DEVICE HISTORY RECORD (DHR) REVIEW DID NOT INDICATE ANY EXCEPTION THAT COULD LEAD TO THE REPORTED INCIDENT. THE AVERAGE LINTING DATA IS 0.105G/10PCS. A SAMPLE WAS NOT RETURNED FOR INVESTIGATION. ACCORDING TO SUPPLIER, THE OR TOWEL IS MADE OF COTTON, SO COTTON FIBER IS BORN. SUPPLIER IS CONTINUOUSLY WORKING WITH CARDINAL HEALTH TO BETTER CONTROL THE LINTING AND HAVE IMPLEMENTED SEVERAL MEASURES TO IMPROVE IT: SUCTION 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), AND 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, THERE IS NO ABNORMAL SITUATION HAPPENED IN PRODUCTION OR DHR. THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. CARDINAL WILL CONTINUE TO MONITOR TRENDS FOR THIS PRODUCT.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THE OR TOWELS WERE DISINTEGRATING AFTER GETTING WET IN THE STERILE SALINE IN THE STERILE BOWLS, DURING A WATCHMAN LEFT ATRIAL APPENDAGE OCCLUSION DEVICE PROCEDURE. FUZZY TYPE PIECES WERE COMING OFF. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203580 TOWEL OR BLUE STERILE FIBER, MEDICAL, ABSORBENT FRL CARDINAL HEALTH 200, LLC 28700-006 220106-18-SH 10630140917257

    Patients

    Seq Age Sex Outcome Treatment
    1 Male