BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOWEL OR 17X24IN GREEN STERILE 4/PK

    MDR report key: 13065097 · Received December 22, 2021

    Report

    Report Number
    1423537-2021-00703
    Event Type
    Malfunction
    Date Received
    December 22, 2021
    Date of Event
    November 19, 2021
    Report Date
    June 27, 2022
    Manufacturer
    JIANERKANG MEDICAL CO LTD
    Product Code
    FRL
    UDI-DI
    50630140010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT BEING FILED FOLLOWING THE INITIAL MDR REPORT 1423537-2021-00703, SINCE THE DEVICE SAMPLE WAS RECEIVED FOR EVALUATION. FROM THE DEVICE HISTORY RECORD (DHR) OF LOT #210504-04-SH, NO EXCEPTION WAS RECORDED IN THE DEVICE HISTORY RECORD THAT COULD LEAD TO THE REPORTED INCIDENT. 4 PIECES OF SAMPLES WERE RETURNED FOR INVESTIGATION. VISUAL TEST AND SUCTION TEST WERE CONDUCTED. NO LINT WAS FOUND. THE LINTING DATA IS 0.07G/4PCS. 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: SUCTION MACHINES HAVE BEEN INSTALLED IN GREY CLOTH ROLLING AND DYEING AND CUTTING PROCESS, THE SUCTION PROCESS WAS ADDED BEFORE PRODUCT'S FINAL FOLDING PER STANDARD OPERATION PROCEDURE REQUIREMENT, LINTING TEST METHOD AND ACCEPTABLE CRITERIA WAS STIPULATED TO SEE THE SUCTION RESULTS. (=0.38G/10PIECES), AND 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, THERE IS NO ABNORMAL SITUATION HAPPENED IN PRODUCTION OR DHR. THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT INFORMATION WAS INFORMED TO THE RELEVANT SECTORS FOR THEIR AWARENESS. WE WILL CONTINUE TO MONITOR THE TREND OF THIS TYPE OF INCIDENT.

    Additional Manufacturer Narrative · 0

    BASED ON SUPPLIER INVESTIGATION, DEVICE HISTORY RECORD (DHR) REVIEW FOR LOT# 210504-04-SH DID NOT INDICATE ANY EXCEPTION THAT COULD LEAD TO THE REPORTED INCIDENT. THE AVERAGE LINTING DATA IS 0.178G/10PCS NO SAMPLE WAS AVAILABLE FOR INVESTIGATION. 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: SUCTION 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 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 OR 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 SUPPLIER WILL CONTINUE TO MONITOR THE TREND OF THIS TYPE OF INCIDENT.

    Description of Event or Problem · 0

    CUSTOMER REPORTED DURING A CARDIAC SURGERY, LINT RESIDUE WAS LEFT ON THE SKIN OF THE PATIENT WHEN TRYING TO REMOVE THE EXCESS CHLOREXIDINE USED TO DISINFECT SKIN OF PATIENT. THERE WAS NO ADVERSE EVENT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1956319 TOWEL OR 17X24IN GREEN STERILE 4/PK FIBER, MEDICAL, ABSORBENT FRL JIANERKANG MEDICAL CO LTD 28200-004 210504-04-SH 50630140010031

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other