BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH LAB PACK (CLNOC)741

    MDR report key: 11783694 · Received May 6, 2021

    Report

    Report Number
    1423537-2021-00633
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Date of Event
    April 8, 2021
    Report Date
    May 6, 2021
    Manufacturer
    MEX03 MEXICO-JUAREZ PRESOURCE
    Product Code
    OEQ
    UDI-DI
    10888439396461
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. THE SUPPLIER REVIEWED RECORDS FOR THE LAST 2 YEARS AND NO ABNORMAL SITUATION WAS FOUND. NO SAMPLE WAS AVAILABLE AT THE TIME OF THE INVESTIGATION. ACCORDING TO THE SUPPLIER, OR 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. (=0.38G/10PIECES). 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. THE INVESTIGATION DETERMINED NO ABNORMAL SITUATION HAPPENED DURING PRODUCTION; 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 THE TREND FOR THIS TYPE OF INCIDENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTS OR TOWEL LINTING SEVERELY. NO PATIENT DEMOGRAPHICS OR ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681344 CATH LAB PACK (CLNOC)741 ANGIOGRAPHY/ANGIOPLASTY KIT OEQ MEX03 MEXICO-JUAREZ PRESOURCE SAN24CLNOD UNKNOWN 10888439396461

    Patients

    Seq Age Sex Outcome Treatment
    1