BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOWEL OR 17X24IN BLUE STERILE 4/PK

    MDR report key: 9673892 · Received February 5, 2020

    Report

    Report Number
    1423537-2020-00410
    Event Type
    Malfunction
    Date Received
    February 5, 2020
    Date of Event
    January 7, 2020
    Report Date
    May 12, 2020
    Manufacturer
    CARDINAL HEALTH SHANGHAI
    Product Code
    FRL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT#190627-16-SH, REVEALED THE PRODUCT WAS MANUFACTURED ON JULY 25, 2019. NO EXCEPTION WAS RECORDED IN THE DEVICE HISTORY RECORD THAT COULD LEAD TO THE REPORTED INCIDENT. PIECES OF THE SAMPLE WAS RETURNED FOR INVESTIGATION. THERE IS NO OBVIOUS LINT FALLING FROM THE SURFACE OF THE TOWEL. SUCTION TEST WAS CONDUCTED, THE LINTING TEST DATA IS 0.08G / 4 PIECES. THE AVERAGE LINTING DATA IS 0.202G / 10 PIECES. ACCORDING TO THE SUPPLIER, OPERATION ROOM 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: A. SUCTIONS 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/10 PIECES). D. IN THE FOLDING PROCESS, (B)(6)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 SHARED WITH 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.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT#190627-16-SH, REVEALED THE PRODUCT WAS MANUFACTURED ON JULY 25, 2019. NO EXCEPTION WAS RECORDED IN THE DEVICE HISTORY RECORD THAT COULD LEAD TO THE REPORTED INCIDENT. NO SAMPLE WAS AVAILABLE AT THE TIME OF THE INVESTIGATION. THE AVERAGE LINTING DATA IS 0.202G / 10 PIECES. 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: A. SUCTIONS 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/10 PIECES). D. IN THE FOLDING PROCESS, JEK 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

    CUSTOMER REPORTED LINT FROM STERILE TOWEL PACKS DURING GSV ABLATION PROCEDURE. NO PATIENT DEMOGRAPHICS WERE PROVIDED AFTER MULTIPLE ATTEMPTS MADE TO RETRIEVE. ALTHOUGH THERE WAS NO INJURY, CARDINAL HEALTH IS PROACTIVELY FILING A MEDWATCH REPORT FOR POTENTIAL RISK TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138015 TOWEL OR 17X24IN BLUE STERILE 4/PK FIBER, MEDICAL, ABSORBENT FRL CARDINAL HEALTH SHANGHAI 28700-004 190627-16-SH

    Patients

    Seq Age Sex Outcome Treatment
    1