BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC CATH PACK (CCMHE)623

    MDR report key: 11606330 · Received April 1, 2021

    Report

    Report Number
    1423537-2021-00619
    Event Type
    Malfunction
    Date Received
    April 1, 2021
    Date of Event
    January 1, 1980
    Report Date
    April 1, 2021
    Manufacturer
    MEX03 MEXICO-JUAREZ PRESOURCE
    Product Code
    OEQ
    UDI-DI
    10888439826364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD REVEALED LOT NUMBER 20200819-23-SH WAS FINISHED ON SEPTEMBER 30TH, 2020. NO EXCEPTION WAS RECORDED IN THE DEVICE HISTORY RECORD THAT COULD LEAD TO THE REPORTED INCIDENT. THE AVERAGE LINTING DATA IS 0.168G / 10 PIECES. NO SAMPLE WAS AVAILABLE AT THE TIME OF INVESTIGATION, BUT PHOTO OF THE LINT FOUND IN GLOVES WAS PROVIDED. ACCORDING TO THE SUPPLIER, OPERATING ROOM TOWEL IS MADE OF COTTON, SO COTTON FIBER IS BORN. THE 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 100PIECES SEMI-FINISHED PRODUCTS TO AVOID LINTING STUCK ONTO THE PRODUCTS DURING PRODUCT'S TRANSFER. BASED ON THE INVESTIGATION, THERE WERE NO ABNORMALITIES FOUND DURING PRODUCTION OF THE OR TOWELS; THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT INFORMATION WAS SHARED WITH THE RELEVANT SECTORS FOR THEIR AWARENESS. NO ACTION TAKEN AT THIS TIME, BUT THE SUPPLIER WILL CONTINUE TO MONITOR TRENDS FOR THIS TYPE OF INCIDENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED OPERATING ROOM TOWELS (PWTB04-STM ) ARE LINTING ON INSTRUMENTS AND CAME IN THE AIR WHEN PACK(SANHFCCMHF) WAS OPENED BEFORE PERIPHERAL PROCEDURE. THE TOWELS WERE REMOVED UPON FINDING LINT AND WAS DISCARDED. THERE WERE NO DELAYS OR INJURY NOTED. NO PATIENT DEMOGRAPHICS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503608 CARDIAC CATH PACK (CCMHE)623 ANGIOGRAPHY/ANGIOPLASTY KIT OEQ MEX03 MEXICO-JUAREZ PRESOURCE SANHFCCMHF 537874 10888439826364

    Patients

    Seq Age Sex Outcome Treatment
    1