BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOWEL OR 17X24IN BLUE STERILE 4/PK

    MDR report key: 10192458 · Received June 24, 2020

    Report

    Report Number
    1423537-2020-00469
    Event Type
    Malfunction
    Date Received
    June 24, 2020
    Date of Event
    May 26, 2020
    Report Date
    June 24, 2020
    Manufacturer
    CARDINAL HEALTH SHANGHAI
    Product Code
    FRL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE DEVICE HISTORY RECORD, LOT#191127-16-SH WAS MANUFACTURED ON 14TH DEC 2019. BASED ON SUPPLIER INVESTIGATION, DEVICE HISTORY RECORD REVIEW DID NOT INDICATE ANY EXCEPTION THAT COULD LEAD TO THE REPORTED INCIDENT. THE AVERAGE LINTING DATA IS 0.165 G/10 PIECES. THERE WERE 19 OCCURRENCES REPORTED IN THE PAST 12 MONTHS. NO SAMPLE WAS AVAILABLE AT THE TIME OF INVESTIGATION BUT A PICTURE WAS PROVIDED THAT SHOWED LINT. ACCORDING TO SUPPLIER, 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: 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 INFORMED TO THE RELEVANT SECTORS FOR THEIR AWARENESS. THERE IS NO ACTION TAKEN AT THIS TIME, BUT SUPPLIER WILL CONTINUE TO MONITOR THE TREND OF THIS TYPE OF INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A HEPATIC ANGIOGRAM, THE STERILE DISPOSABLE OR TOWELS 28700-004 WERE LINTING. THE TOWELS WERE USED FOR PATIENT PREP, PATIENT DRAPING AND LAID ON THE FIELD DURING THE PROCEDURE TO HOLD WIRES DOWN AND TO ABSORB LIQUIDS FORM THE FIELD. LINT WAS FOUND ON WIRES, STERILE FIELD, STERILE TABLE AND GLOVES. CUSTOMER REPORTED THERE WAS NO INJURY, PATIENT WAS NOT AFFECTED AND THERE WAS NO DELAY IN PROCEDURE. NO PATIENT DEMOGRAPHICS WERE PROVIDED UPON REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652235 TOWEL OR 17X24IN BLUE STERILE 4/PK FIBER, MEDICAL, ABSORBENT FRL CARDINAL HEALTH SHANGHAI 28700-004 191127-16-SH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other