BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOWEL OR 17X24IN BLUE STERILE 4/PK

    MDR report key: 8898885 · Received August 15, 2019

    Report

    Report Number
    1423537-2019-00338
    Event Type
    Malfunction
    Date Received
    August 15, 2019
    Date of Event
    July 19, 2019
    Report Date
    August 15, 2019
    Manufacturer
    JIANERKANG MEDICAL DRESSING CO, LTD
    Product Code
    NAB
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THE INVESTIGATION A REVIEW OF THE DEVICE HISTORY RECORD SHOWED LOT#190315-16-SH WAS MANUFACTURED ON 11TH APR 2019. THE DEVICE HISTORY RECORD REVIEW DID NOT INDICATE ANY EXCEPTION THAT WOULD HAVE LED TO THE REPORTED INCIDENT. THE SUPPLIER CHECKED ON RETAINED SAMPLE. THE AVERAGE LINTING DATA WAS 0.150G/ 10 PIECES AND WITHIN NORMAL LIMITS (=0.38G/10 PIECES). NO SAMPLE WAS PROVIDED FOR INVESTIGATION AT THIS TIME. ACCORDING TO OUR SUPPLIER, THE OR TOWEL IS MADE OF COTTON, SO 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. LINTING TEST METHOD AND ACCEPTABLE CRITERIA WAS STIPULATED TO SEE THE SUCTION RESULTS. (=0.38G/10 PIECES). 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. BASED ON THE INVESTIGATION, ALL LINTING TEST DATA WAS WITHIN THE ACCEPTABLE RANGE. THERE WAS NO ABNORMAL SITUATION THAT HAD HAPPENED IN PRODUCTION. THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED AND NO FURTHER ACTION TAKEN. THE COMPLAINT INFORMATION WAS SHARED WITH THE RELEVANT SECTORS WITHIN THE MANUFACTURING FACILITY FOR THEIR AWARENESS AND WE WILL CONTINUE TO MONITOR FOR THIS TYPE OF INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER HAD REPORTED FINDING EXCESSIVE LINT FROM THE STERILE BLUE OR TOWELS 28700-004, LOT NUMBER 190315-16-SH DURING AN OPEN HEART PROCEDURE. NO PATIENT CLINICAL DATA OR PATIENT DEMOGRAPHICS WERE PROVIDED AFTER MULTIPLE ATTEMPTS TO RETRIEVE FROM CUSTOMER. THERE WAS NO PATIENT INJURY REPORTED. AN MDR IS BEING FILED BASED ON POTENTIAL RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691051 TOWEL OR 17X24IN BLUE STERILE 4/PK GAUZE/SPONGE,NONRESORBABLE FOR EXTERNAL USE NAB JIANERKANG MEDICAL DRESSING CO, LTD 28700-004 190315-16-SH

    Patients

    Seq Age Sex Outcome Treatment
    1