BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOWEL OR 17X24IN BLUE STERILE 4/PK

    MDR report key: 10243055 · Received July 7, 2020

    Report

    Report Number
    1423537-2020-00478
    Event Type
    Malfunction
    Date Received
    July 7, 2020
    Date of Event
    June 11, 2020
    Report Date
    July 7, 2020
    Manufacturer
    CARDINAL HEALTH SHANGHAI
    Product Code
    FRL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS FOR LOT NUMBERS 200212-16-SH AND 190626-16-SH REVEALED NO EXCEPTIONS WERE RECORDED THAT COULD LEAD TO THE REPORTED INCIDENT. LOT NUMBER 200212-16-SH WAS MANUFACTURED ON MARCH 20TH, 2020 AND LOT NUMBER 190626-16-SH WAS MANUFACTURED ON JULY 25TH, 2019. BASED ON SUPPLIER INVESTIGATION FOR LOT NUMBER 200212-16-SH, THE AVERAGE LINTING DATA IS 0.164 G / 10 PIECES AND THE AVERAGE LINTING DATA FOR LOT 190626-16-SH IS 0.192 G / 10 PIECES. NO SAMPLES WERE AVAILABLE IT THE TIME OF THE INVESTIGATION, BUT PHOTOS WERE PROVIDED. LINT WAS FOUND ON THE WIRES. ACCORDING TO SUPPLIER, OR TOWEL IS MADE OF COTTON, SO COTTON FIBER IS BORN. 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. (=0.38 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. FROM THE INVESTIGATION, NO ABNORMAL SITUATION HAPPENED IN PRODUCTION; THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT INFORMATION WAS SHARED WITH THE RELEVANT SECTORS FOR THEIR AWARENESS. THERE IS NO ACTION TAKEN AT THIS TIME, BUT THE SUPPLIER WILL CONTINUE TO MONITOR TRENDS FOR THIS TYPE OF INCIDENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED LINT ON BLUE TOWELS DURING ENDOVASCULAR COIL EMBOLIZATION OF A LEFT INTERNAL CAROTID ARTERY ANEURYSM. TWO LOT NUMBERS WERE USED ON THE PATIENT. THE CASE WAS DELAYED ROUGHLY 20 MINUTES, BUT NO INJURY TO THE PATIENT REPORTED. CARDINAL HEALTH IS FILING A REPORT FOR POTENTIAL RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705480 TOWEL OR 17X24IN BLUE STERILE 4/PK FIBER, MEDICAL, ABSORBENT FRL CARDINAL HEALTH SHANGHAI 28700-004 200212-16-SH

    Patients

    Seq Age Sex Outcome Treatment
    1