BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOWEL OR 17X24IN BLUE STERILE 4/PK

    MDR report key: 9617992 · Received January 22, 2020

    Report

    Report Number
    1423537-2020-00397
    Event Type
    Malfunction
    Date Received
    January 22, 2020
    Date of Event
    November 22, 2019
    Report Date
    January 22, 2020
    Manufacturer
    CARDINAL HEALTH SHANGHAI
    Product Code
    FRL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE DEVICE HISTORY RECORD, LOT#190628-16-SH WAS MANUFACTURED ON 25TH JUL 2019. NO EXCEPTION WAS RECORDED IN THE DEVICE HISTORY RECORD THAT COULD LEAD TO THE REPORTED INCIDENT. THE AVERAGE LINTING DATA IS 0.207G / 10 PIECES. NO SAMPLE WAS AVAILABLE AT THE TIME OF THE INVESTIGATION. ACCORDING TO THE SUPPLIER, OR TOWEL IS MADE OF COTTON, SO COTTON FIBER IS BORN AND INEVITABLE. 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. (=0.38G/10 PIECES). IN THE FOLDING PROCESS, THE 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 AND ALL LINTING TEST DATA WERE WITHIN THE ACCEPTABLE RANGE. 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 WE WILL CONTINUE TO MONITOR THE TREND OF THIS TYPE OF INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY FOUND LARGE AMOUNTS OF LINT FROM THE BLUE OR TOWELS 28700-004 ON THE INSTRUMENTS AND PATIENT DURING A CRANIOTOMY. THE TOWELS WERE DRAPED ON THE MAYO STAND WHERE THE INSTRUMENTS GO AND ON THE BACK TABLE COVER . NO INJURY OCCURRED. CARDINAL HEALTH IS FILING A REPORT BASED ON POTENTIAL RISK TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82170 TOWEL OR 17X24IN BLUE STERILE 4/PK FIBER, MEDICAL, ABSORBENT FRL CARDINAL HEALTH SHANGHAI 28700-004 190628-16-SH

    Patients

    Seq Age Sex Outcome Treatment
    1