BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC CATH PACK (CCEDC)677

    MDR report key: 15810473 · Received November 16, 2022

    Report

    Report Number
    1423537-2022-00858
    Event Type
    Malfunction
    Date Received
    November 16, 2022
    Date of Event
    October 26, 2022
    Report Date
    November 16, 2022
    Manufacturer
    CARDINAL HEALTH 200 LLC
    Product Code
    OES
    UDI-DI
    10888439629866
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORD COULD NOT BE VERIFIED AS LOT NUMBER WAS NOT PROVIDED. A SAMPLE WAS NOT RECEIVED FOR INVESTIGATION. ACCORDING TO OUR SUPPLIER, THE CLOTH TOWEL IS SINGLE USE PRODUCT. IT 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 (SOP) REQUIREMENT, C. LINTING TEST METHOD AND ACCEPTABLE CRITERIA WAS STIPULATED TO SEE THE SUCTION RESULTS. (=0.38G/10PIECES), D. IN THE FOLDING PROCESS, SUPPLIER USED ONE CLOTH PAD UNDER EACH STACK PRODUCTS TO AVOID LINTING STUCK ONTO THE PRODUCTS DURING PRODUCT'S TRANSFER. FROM THE INVESTIGATION, THERE IS NO ABNORMAL SITUATION HAPPENED IN PRODUCTION. THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT DURING A CARDIAC CATHETERIZATION PROCEDURE, THE CLOTH TOWELS PWTB04-STM FROM THE CARDIAC CATHETERIZATION PACK SAN46CCEDD WERE LINTING. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER UPON REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1830777 CARDIAC CATH PACK (CCEDC)677 CARDIAC CATHETERIZATION KIT OES CARDINAL HEALTH 200 LLC SAN46CCEDD UNKNOWN 10888439629866

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown