BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCLAREN CATH LAB PACK 639

    MDR report key: 9304874 · Received November 11, 2019

    Report

    Report Number
    1423537-2019-00372
    Event Type
    Malfunction
    Date Received
    November 11, 2019
    Date of Event
    October 22, 2019
    Report Date
    November 11, 2019
    Manufacturer
    MEX03 MEXICO-JUAREZ PRESOURCE
    Product Code
    LRO
    UDI-DI
    10888439531237
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON SUPPLIER INVESTIGATION, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED, AS THE LOT NUMBER WAS NOT PROVIDED. AT THE TIME OF THIS INVESTIGATION NO SAMPLES HAD NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE COULD NOT BE DETERMINED FROM THIS INVESTIGATION. THE COMPLAINT INFORMATION WAS INFORMED TO THE RELEVANT SECTORS FOR THEIR AWARENESS. THERE IS NO ACTION TAKEN AT THIS TIME, HOWEVER, THE SUPPLIER WILL CONTINUE TO MONITOR THE TREND OF THIS TYPE OF INCIDENT. 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

    BASED ON INFORMATION RECEIVED FROM THE CUSTOMER, THERE WAS REPORTEDLY LINTING BLUE TOWELS IN PACK. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097371 MCLAREN CATH LAB PACK 639 GENERAL SURGERY TRAY (KIT) LRO MEX03 MEXICO-JUAREZ PRESOURCE SANRPCLMLA UNKNOWN 10888439531237

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other