BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOGRAPHY PACK (ANWRB)612

    MDR report key: 9604635 · Received January 17, 2020

    Report

    Report Number
    1423537-2020-00394
    Event Type
    Malfunction
    Date Received
    January 17, 2020
    Date of Event
    November 6, 1979
    Report Date
    February 17, 2020
    Manufacturer
    MEX03 MEXICO-JUAREZ PRESOURCE
    Product Code
    LRO
    UDI-DI
    10887488564388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT IS BEING FILED SINCE 4 PIECES OF THE BLUE OPERATING ROOM TOWELS PWTB04-STM WERE RETURNED FOR INVESTIGATION. THERE IS NO OBVIOUS LINT FALLING FROM THE SURFACE OF THE TOWEL. THE LINTING TEST DATA IS 0.09G / 4 PIECES. ACCORDING TO SUPPLIER, OR TOWEL IS MADE OF COTTON, SO LINT IS BORN AND INEVITABLE. THE SUPPLIER IS CONTINUOUSLY WORKING WITH CARDINAL HEALTH TO BETTER CONTROL THE LINTING AND HAS IMPLEMENTED SEVERAL MEASURES TO IMPROVE IT: A. SUCTIONS MACHINES HAVE BEEN INSTALLED IN GREY CLOTH ROLLING PROCESS, DYEING PROCESS AND CUTTING PROCESS. B. THE SUCTION PROCESS WAS ADDED BEFORE PRODUCT'S FINAL FOLDING, AND WORKERS DO IT ACCORDING TO STANDARD OPERATION PROCEDURE REQUIREMENT. C. LINTING TEST METHOD AND ACCEPTABLE CRITERIA WAS STIPULATED TO SEE THE SUCTION RESULTS. (=0.38G/10 PIECES). D. IN THE FOLDING PROCESS, SUPPLIER USED ONE CLOTH PAD UNDER 100 PIECES SEMI-FINISHED PRODUCTS TO AVOID LINTING STUCK ONTO THE PRODUCTS DURING PRODUCT'S TRANSFER. FROM THE INVESTIGATION, THERE IS NO ABNORMAL SITUATION HAPPENED IN PRODUCTION. THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT INFORMATION WAS INFORMED TO THE RELEVANT SECTORS FOR THEIR AWARENESS. THERE IS NO ACTION TAKEN AT THIS TIME, BUT SUPPLIER WILL CONTINUE TO MONITOR THE TREND OF THIS TYPE OF INCIDENT.

    Additional Manufacturer Narrative · 1

    BASED ON THE SUPPLIER INVESTIGATION, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS LOT NUMBER WAS NOT PROVIDED. A SAMPLE WAS NOT AVAILABLE AT THE TIME OF THE INVESTIGATION. ACCORDING TO SUPPLIER, OR TOWEL IS MADE OF COTTON, SO LINT IS BORN AND INEVITABLE. THE SUPPLIER IS CONTINUOUSLY WORKING WITH CARDINAL HEALTH TO BETTER CONTROL THE LINTING AND HAS 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, SUPPLIER USED ONE CLOTH PAD UNDER 100 PIECES SEMI-FINISHED PRODUCTS TO AVOID LINTING STUCK ONTO THE PRODUCTS DURING PRODUCT'S TRANSFER. FROM THE INVESTIGATION, THERE IS NO ABNORMAL SITUATION HAPPENED IN PRODUCTION. THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT INFORMATION WAS INFORMED TO THE RELEVANT SECTORS FOR THEIR AWARENESS. THERE IS NO ACTION TAKEN AT THIS TIME, BUT SUPPLIER WILL CONTINUE TO MONITOR THE TREND OF THIS TYPE OF INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LINTING OF THE BLUE OR TOWELS PWTB04-STM FROM THE ANGIOGRAPHY PACK SAN22ANWRC DURING A CARDIAC CATHETER PROCEDURE. LINT WAS FOUND ON GLOVES, TOWELS AND IN FLUID CONTAINERS. THE TOWELS WERE USED OVER TOP OF DRAPE TO ABSORB EXCESS FLUID. NO APPARENT NEGATIVE PATIENT OUTCOMES OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED AFTER GLOVES WERE CHANGED, LINTING TOWELS REMOVED AND FLUID CONTAINERS WERE EMPTIED. ALTHOUGH THERE WAS NO INJURY, CARDINAL HEALTH IS FILING A MEDWATCH REPORT FOR POTENTIAL RISK TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65761 ANGIOGRAPHY PACK (ANWRB)612 GENERAL SURGERY TRAY (KIT) LRO MEX03 MEXICO-JUAREZ PRESOURCE SAN22ANWRC UNKNOWN 10887488564388

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other