BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOWEL OR 17X24IN BLUE STERILE 4/PK

    MDR report key: 10363909 · Received August 4, 2020

    Report

    Report Number
    1423537-2020-00495
    Event Type
    Malfunction
    Date Received
    August 4, 2020
    Date of Event
    July 3, 2020
    Report Date
    August 4, 2020
    Manufacturer
    CARDINAL HEALTH SHANGHAI
    Product Code
    FRL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE DEVICE HISTORY RECORD, LOT# 190812-16-SH WAS MANUFACTURED ON 29TH AUG 2019. NO EXCEPTION WAS RECORDED IN THE DEVICE HISTORY RECORD THAT COULD LEAD TO THE REPORTED INCIDENT. THE AVERAGE LINTING DATA IS 0.210 G / 10 PIECES. THERE ARE 22 OCCURRENCES REPORTED IN THE PAST 12 MONTHS. SAMPLE PHOTOS WERE PROVIDED FOR INVESTIGATION WHICH SHOWED LINT ON THE SURFACE OF THE PRODUCT BUT PHYSICAL SAMPLE WAS NOT AVAILABLE. 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 WERE 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, NO EXCEPTIONS WERE NOTED IN THE DEVICE HISTORY RECORD AND NO SAMPLE WAS AVAILABLE FOR INVESTIGATION. 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 THAT BEFORE A SPINAL FUSION PROCEDURE, LINT FROM THE OPERATING ROOM TOWELS 28700-004 WERE FOUND ON THE HANDS OF THE SURGEON AND ASSISTANT AFTER SCRUBBING. THE TOWELS WERE NOT USED ON THE PATIENT. NO INJURY REPORTED AND NO PATIENT DEMOGRAPHICS PROVIDED. REPORT BEING FILED FOR POTENTIAL PATIENT RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827346 TOWEL OR 17X24IN BLUE STERILE 4/PK FIBER, MEDICAL, ABSORBENT FRL CARDINAL HEALTH SHANGHAI 28700-004 190812-16-SH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other