BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOWEL OR 17X24IN GREEN STERILE 2/PK

    MDR report key: 10693297 · Received October 16, 2020

    Report

    Report Number
    1423537-2020-00546
    Event Type
    Malfunction
    Date Received
    October 16, 2020
    Date of Event
    October 1, 2020
    Report Date
    November 6, 2020
    Manufacturer
    CARDINAL HEALTH SHANGHAI
    Product Code
    FRL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT BEING FILED DUE TO A PHOTO OF THE PRODUCT DEFECT WAS RECEIVED AFTER THE INITIAL MDR REPORT 1423537-2020-00546 WAS FILED. 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 0.155G / 10 PIECES. THERE IS 1 OCCURRENCE REPORTED IN THE PAST 12 MONTHS. NO SAMPLE AVAILABLE FOR INVESTIGATION. PHOTOS WERE PROVIDED. LINT WAS FOUND ON THE GLOVES. 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: A. SUCTION MACHINES HAVE BEEN INSTALLED IN GREY CLOTH ROLLING PROCESS, DYEING PROCESS AND CUTTING PROCESS. B. THE SUCTION PROCESS WAS ADDED BEFORE PRODUCT'S FINAL FOLDING, AND WORKERS DO IT ACCORDING TO STANDARD OPERATION PROCEDURE REQUIREMENT. C. LINTING TEST METHOD AND ACCEPTABLE CRITERIA WAS STIPULATED TO SEE THE SUCTION RESULTS. (=0.38G/10PIECES). D. IN THE FOLDING PROCESS, SUPPLIER USED ONE CLOTH PAD UNDER 100PIECES SEMI-FINISHED PRODUCTS TO AVOID LINTING STUCK ONTO THE PRODUCTS DURING PRODUCT'S TRANSFER. FROM THE INVESTIGATION, NO ABNORMAL SITUATION HAPPENED IN PRODUCTION AND DHR. THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    BASED ON THE SUPPLIER INVESTIGATION, THE DEVICE HISTORY RECORD (DHR) REVIEW DID NOT INDICATE ANY EXCEPTION THAT COULD LEAD TO THE REPORTED INCIDENT. THE AVERAGE LINTING DATA IS 0.155G /10 PIECES. THERE IS 1 OCCURRENCE REPORTED IN THE PAST 12 MONTHS. NO SAMPLE WAS AVAILABLE FOR INVESTIGATION. ACCORDING TO THE 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: 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/10PIECES). IN THE FOLDING PROCESS, SUPPLIER USED ONE CLOTH PAD UNDER 100PIECES SEMI-FINISHED PRODUCTS TO AVOID LINTING STUCK ONTO THE PRODUCTS DURING PRODUCT'S TRANSFER. FROM THE INVESTIGATION, NO ABNORMAL SITUATION OCCURRED IN PRODUCTION AND DHR. 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 THE SUPPLIER WILL CONTINUE TO MONITOR THE TREND OF THIS TYPE OF INCIDENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HIGH AMOUNTS OF LINT ON THE OR TOWELS 28200-002 FOUND ON THE SURGICAL INSTRUMENTS DURING A BRAIN SURGERY. THE LINT WAS SEEN AND REMOVED UNDER OPERATING MICROSCOPE AND PATIENT HAD NO ADVERSE EVENTS. NO PATIENT DEMOGRAPHICS OR FURTHER CLINICAL DATA WAS PROVIDED WHEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152890 TOWEL OR 17X24IN GREEN STERILE 2/PK FIBER, MEDICAL, ABSORBENT FRL CARDINAL HEALTH SHANGHAI 28200-002 191026-03-SH

    Patients

    Seq Age Sex Outcome Treatment
    1