BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC CATH PACK SSP (CCSTH)626

    MDR report key: 9211056 · Received October 18, 2019

    Report

    Report Number
    1423537-2019-00363
    Event Type
    Malfunction
    Date Received
    October 18, 2019
    Date of Event
    September 25, 2019
    Report Date
    October 18, 2019
    Manufacturer
    MEX03 MEXICO-JUAREZ PRESOURCE
    Product Code
    LRO
    UDI-DI
    10887488809700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON SUPPLIER INVESTIGATION, THE DEVICE HISTORY RECORD, LOT# 20190717-23-SH WAS MANUFACTURED ON 25TH JUL 2019. NO EXCEPTION WAS RECORDED IN THE DEVICE HISTORY RECORD THAT COULD LEAD TO THE REPORTED INCIDENT. THE AVERAGE LINTING DATA IS 0.205G / 10 PIECES. NO SAMPLE WAS RETURNED TO THE SUPPLIER AT THE TIME OF THE INVESTIGATION, ONLY A PHOTO WITH LITTLE BLUE LINT ON THE WHITE GAUZE WAS PROVIDED. ACCORDING TO THE MANUFACTURER, THE OR TOWEL IS MADE OF COTTON, SO LINT IS BORN AND INEVITABLE. THE INTENDED USE OF OR TOWEL IS USED FOR APPLYING MEDICATION OR ABSORBING SMALL AMOUNTS OF BODY FLUIDS FROM A PATIENT'S BODY SURFACE. THE MANUFACTURER WILL CONTINUE TO WORK WITH CARDINAL HEALTH TO BETTER CONTROL THE LINTING AND THEY HAVE IMPLEMENTED SEVERAL MEASURES TO IMPROVE IT: THE SUCTION PROCESS WAS ADDED BEFORE PRODUCTS' FINAL FOLDING AND OPERATORS DO IT ACCORDING TO STANDARD OPERATION PROCEDURE REQUIREMENTS. LINTING TEST METHOD AND ACCEPTABLE CRITERIA WAS STIPULATED TO SEE THE SUCTION RESULTS (=0.38G/10 PIECES). IN THE FOLDING PROCESS, THE MANUFACTURER USED ONE CLOTH BAG PROTECT 100 PIECES SEMI-FINISHED PRODUCTS TO AVOID LINTING STUCK ONTO THE PRODUCTS DURING PRODUCTS' TRANSFER. FROM THE INVESTIGATION, NO ABNORMAL SITUATION HAPPENED IN PRODUCTION AND ALL LINTING TEST DATA WERE WITHIN THE ACCEPTABLE RANGE. THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT INFORMATION WAS SHARED WITH THE RELEVANT SECTORS WITHIN THE MANUFACTURING FACILITY FOR THEIR AWARENESS AND WE WILL CONTINUE TO MONITOR FOR THIS TYPE OF INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE OR TOWELS/ PWTB04-STM FROM THE CARDIAC CATHETER PACK/ SCV5CCCSTI WERE LINTING DURING A CORONARY ANGIOGRAM. THE TOWELS WERE USED TO ABSORB BLOOD AND FLUID ON THE PATIENT'S DRAPE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT HARM. NO PATIENT DEMOGRAPHICS WERE PROVIDED. ALTHOUGH THERE WAS NO INJURY, CARDINAL HEALTH IS PROACTIVELY FILING A MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005771 CARDIAC CATH PACK SSP (CCSTH)626 GENERAL SURGERY TRAY (KIT) LRO MEX03 MEXICO-JUAREZ PRESOURCE SCV5CCCSTI 299570 10887488809700

    Patients

    Seq Age Sex Outcome Treatment
    1 Other