BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOWEL OR 17X24IN BLUE STERILE 4/PK

    MDR report key: 8276904 · Received January 25, 2019

    Report

    Report Number
    1423537-2019-00256
    Event Type
    Malfunction
    Date Received
    January 25, 2019
    Date of Event
    January 1, 1980
    Report Date
    April 10, 2019
    Manufacturer
    JIANERKANG MEDICAL DRESSING CO, LTD
    Product Code
    NAB
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS INVESTIGATION THE DEVICE HISTORY RECORD COULD NOT BE VERIFIED, AS A LOT NUMBER WAS NOT PROVIDED. HOWEVER, (B)(4) (SUPPLIER) CHECKED ON THE DEVICE HISTORY RECORD FOR THE PAST 2 YEARS AND DID NOT FIND ANY LINTING DATA =0.38G/10PIECES. A SAMPLE WAS NOT PROVIDED FOR EVALUATION, BUT OUR BLUE OR TOWEL IS CLASSIFIED AS A ¿LOW LINT COTTON OR TOWEL¿ AND SINCE THE TOWEL IS MADE OF COTTON, SOME LINT IS INEVITABLE. OUR 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 HAS BEEN ADDED BEFORE THE PRODUCT'S FINAL FOLDING, AND WORKERS DO IT ACCORDING TO STANDARD OPERATION PROCEDURE REQUIREMENT. LINTING TEST METHOD AND ACCEPTABLE CRITERIA HAS BEEN STIPULATED TO SEE THE SUCTION RESULTS. (=0.38G/10PIECES). IN THE FOLDING PROCESS, OUR SUPPLIER USES ONE CLOTH PAD UNDER 100 PIECES SEMI-FINISHED PRODUCTS TO AVOID LINTING BEING STUCK ONTO THE PRODUCTS DURING PRODUCT'S TRANSFER. BASED ON THE INVESTIGATION, THERE IS NO ABNORMAL SITUATION NOTED THAT MAY HAVE 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 OTHER ACTION TAKEN AT THIS TIME, HOWEVER, OUR SUPPLIER WILL CONTINUE TO MONITOR THE TREND OF THIS TYPE OF INCIDENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR LOT NUMBERS 180718-16-SH AND 180927-16-SH WERE REVIEWED. NO EXCEPTION WAS RECORDED IN THE DEVICE HISTORY RECORD THAT COULD LEAD TO THE REPORTED INCIDENT. THE AVERAGE LINTING DATA IS 0.212G / 10 PIECES AND 0.122G / 10 PIECES. EIGHT PIECES OF SAMPLES WITH LOT NUMBERS 180718-16-SH AND 180927-16-SH WERE RETURNED FOR INVESTIGATION. THERE WAS NO LINT FOUND ON THE SURFACE. THE SUPPLIER PERFORMED THE LINTING TEST AND THE LINTING DATA IS 0.078G AND 0.056G, WHICH IS WITHIN THE ACCEPTABLE CRITERIA =0.38G/10PIECES. ACCORDING TO THE SUPPLIER, OR TOWELS ARE MADE OF COTTON, THEREFORE, LINT IS BORN AND INEVITABLE. OUR 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. BESIDES, LINTING TEST METHOD AND ACCEPTABLE CRITERIA WAS STIPULATED TO SEE THE SUCTION RESULTS. (=0.38G/10PIECES). D. IN THE FOLDING PROCESS, THE SUPPLIER USED ONE CLOTH PAD UNDER 100 PIECES SEMI-FINISHED PRODUCTS TO AVOID LINTING STUCK ONTO THE PRODUCTS DURING PRODUCT'S TRANSFER. NO EXCEPTION WAS RECORDED IN THE DEVICE HISTORY RECORD THAT COULD LEAD TO THE REPORTED INCIDENT. 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, HOWEVER WE WILL CONTINUE TO MONITOR THE TREND OF THIS TYPE OF INCIDENT.

    Description of Event or Problem · 1

    BASED ON INFORMATION RECEIVED FROM THE HOSPITAL REPRESENTATIVE, LINT FROM THE CARDINAL HEALTH STERILE TOWELS IS REPORTEDLY GETTING ONTO OTHER PRODUCT DURING CASES. PER THE HOSPITAL REPRESENTATIVE, THERE WAS NO INJURY TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69709 TOWEL OR 17X24IN BLUE STERILE 4/PK GAUZE/SPONGE,NONRESORBABLE FOR EXTERNAL USE NAB JIANERKANG MEDICAL DRESSING CO, LTD 28700-004 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1