BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH LAB PACK (CLARC)184

    MDR report key: 11611293 · Received April 2, 2021

    Report

    Report Number
    1423537-2021-00620
    Event Type
    Malfunction
    Date Received
    April 2, 2021
    Date of Event
    February 26, 2021
    Report Date
    April 2, 2021
    Manufacturer
    MEX03 MEXICO-JUAREZ PRESOURCE
    Product Code
    OEQ
    UDI-DI
    10888439838305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE DEVICE HISTORY RECORD, LOT# 20200226-23-SH WAS FINISHED ON 27TH MAR 2020. NO EXCEPTION WAS RECORDED IN THE DEVICE HISTORY RECORD THAT COULD LEAD TO THE REPORTED INCIDENT. 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 0.151G / 10 PIECES. NO SAMPLE WAS RETURNED FOR INVESTIGATION. IF A SAMPLE IS RECEIVED AT A LATER DATE, A FOLLOW UP REPORT WILL BE MADE. ACCORDING TO SUPPLIER, OPERATING ROOM TOWEL IS MADE OF COTTON, SO COTTON FIBER IS BORN. SUPPLIER CONTINUOUSLY WORKING WITH CAH 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. (B)(4) D. 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, 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 SUPPLIER WILL CONTINUE TO MONITOR THE TREND OF THIS TYPE OF INCIDENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED LINTING OF THE BLUE, NON-XRAY COTTON TOWELS PWTB04-STM FROM THE CATH LAB PACK SAN21CLARD FOUND ON WIRE DURING A CORONARY INTERVENTION. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505110 CATH LAB PACK (CLARC)184 ANGIOGRAPHY/ANGIOPLASTY KIT OEQ MEX03 MEXICO-JUAREZ PRESOURCE SAN21CLARD 543289 10888439838305

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other