BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCULAR ANGIOGRAPHY PACK (AGFTB)255

    MDR report key: 9579344 · Received January 11, 2020

    Report

    Report Number
    1423537-2020-00392
    Event Type
    Malfunction
    Date Received
    January 11, 2020
    Date of Event
    December 13, 2019
    Report Date
    January 11, 2020
    Manufacturer
    MEX03 MEXICO-JUAREZ PRESOURCE
    Product Code
    LRO
    UDI-DI
    10888439507645
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE SUPPLIER INVESTIGATION, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS A LOT NUMBER WAS NOT PROVIDED. AT THE TIME OF THIS INVESTIGATION NO SAMPLE HAS BEEN RETURNED. FROM THE INVESTIGATION, THERE WAS NO ABNORMAL SITUATION WHICH HAS HAPPENED DURING PRODUCTION. THE ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT INFORMATION WAS PROVIDED TO THE RELEVANT SECTORS FOR THEIR AWARENESS. ACCORDING TO OUR SUPPLIER, OR TOWELS ARE MADE OF COTTON, SO LINT IS BORN AND INEVITABLE. 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/10 PIECES). IN THE FOLDING PROCESS, THE SUPPLIER USED ONE CLOTH PAD UNDER 100 PIECES SEMI-FINISHED PRODUCTS TO AVOID LINTING STUCK ONTO THE PRODUCTS DURING PRODUCT'S TRANSFER.

    Description of Event or Problem · 1

    PER CUSTOMER, PIECES OF LINT COMES OFF OF THE TOWEL AND ALLEGEDLY ARE LEAVING A LOT OF LINT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42278 VASCULAR ANGIOGRAPHY PACK (AGFTB)255 GENERAL SURGERY TRAY (KIT) LRO MEX03 MEXICO-JUAREZ PRESOURCE SANHFAGFTC UNKNOWN 10888439507645

    Patients

    Seq Age Sex Outcome Treatment
    1