BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT,OPEN HEART CON (HCOB )933

    MDR report key: 11812099 · Received May 12, 2021

    Report

    Report Number
    1423537-2021-00635
    Event Type
    Malfunction
    Date Received
    May 12, 2021
    Date of Event
    April 26, 2021
    Report Date
    May 12, 2021
    Manufacturer
    MEX03 MEXICO-JUAREZ PRESOURCE
    Product Code
    OEZ
    UDI-DI
    10888439839852
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON SUPPLIER INVESTIGATION, DEVICE HISTORY RECORD (DHR) REVIEW DID NOT INDICATE ANY EXCEPTIONS THAT COULD LEAD TO THE REPORTED INCIDENT. THE AVERAGE LINTING DATA IS 0.157G/10PCS. NO SAMPLE WAS AVAILABLE AT THE TIME OF INVESTIGATION. ACCORDING TO SUPPLIER, OR TOWEL IS MADE OF COTTON, SO COTTON FIBER IS BORN. SUPPLIER CONTINUOUSLY WORKING WITH CARDINAL HEALTH TO BETTER CONTROL THE LINTING AND HAVE IMPLEMENTED SEVERAL MEASURES TO IMPROVE IT: SUCTION 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)/(B)(4)PIECES). IN THE FOLDING PROCESS, SUPPLIER USED ONE CLOTH PAD UNDER (B)(4)PIECES SEMI-FINISHED PRODUCTS TO AVOID LINTING STUCK ONTO THE PRODUCTS DURING PRODUCT'S TRANSFER. THE ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT INFORMATION WAS SHARED WITH THE RELEVANT SECTORS FOR THEIR AWARENESS. THERE IS NO ACTION TAKEN AT THIS TIME, BUT THE SUPPLIER WILL CONTINUE TO MONITOR THE TREND OF THIS TYPE OF INCIDENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED LINT ON THE BLUE TOWELS PWTB04-STM FROM OPEN HEART KIT, PVCGOHCOB. LINT WAS FOUND PRIOR TO PROCEDURE WITH NO DELAY OR AFFECT TO PATIENT. NO CLINICAL DATA OR PATIENT DEMOGRAPHICS WERE PROVIDED AFTER NUMEROUS ATTEMPTS TO OBTAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710429 KIT,OPEN HEART CON (HCOB )933 CARDIOVASCULAR PROCEDURE KIT OEZ MEX03 MEXICO-JUAREZ PRESOURCE PVCGOHCOB 554772 10888439839852

    Patients

    Seq Age Sex Outcome Treatment
    1 Other