BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOLOGY PACK MMMC (CPMMJ)808

    MDR report key: 11809850 · Received May 11, 2021

    Report

    Report Number
    1423537-2021-00634
    Event Type
    Malfunction
    Date Received
    May 11, 2021
    Date of Event
    April 20, 2021
    Report Date
    May 11, 2021
    Manufacturer
    MEX03 MEXICO-JUAREZ PRESOURCE
    Product Code
    OEQ
    UDI-DI
    10888439429282
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON SUPPLIER INVESTIGATION, DEVICE HISTORY RECORD (DHR) REVIEW DID NOT INDICATE ANY EXCEPTION THAT COULD LEAD TO THE REPORTED INCIDENT. THE AVERAGE LINTING DATA IS 0.164G/10PCS. NO SAMPLE WAS RETURNED FOR INVESTIGATION. ACCORDING TO THE SUPPLIER, THE OPERATING ROOM 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 WAS STIPULATED TO SEE THE SUCTION RESULTS. (B)(4). 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. 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 THE BLUE COTTON OPERATING ROOM TOWELS PWTB04-STM FROM THE CARDIOLOGY PACK SAN55CPMMJ ARE FRAGMENTING LINT MATERIAL AND ADHERING TO THE SURGICAL DEVICES. ISSUE WAS FOUND DURING SETUP PRIOR TO PATIENT CONTACT. THERE WAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705366 CARDIOLOGY PACK MMMC (CPMMJ)808 ANGIOGRAPHY/ANGIOPLASTY KIT OEQ MEX03 MEXICO-JUAREZ PRESOURCE SAN55CPMMJ 574167 10888439429282

    Patients

    Seq Age Sex Outcome Treatment
    1 Other