BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACK ANGIO CVL KNPW (RAKPH)816

    MDR report key: 11732927 · Received April 27, 2021

    Report

    Report Number
    1423537-2021-00628
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    March 29, 2021
    Report Date
    April 27, 2021
    Manufacturer
    MEX03 MEXICO-JUAREZ PRESOURCE
    Product Code
    OEQ
    UDI-DI
    10888439854916
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON SUPPLIER INVESTIGATION, DEVICE HISTORY RECORD (DHR) REVIEW DID NOT INDICATE ANY EXCEPTION THAT COULD LEAD TO THE REPORTED INCIDENT. THE AVERAGE LINTING DATA IS 0.136G/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: 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/10PIECES). IN THE FOLDING PROCESS, SUPPLIER USED ONE CLOTH PAD UNDER 100PIECES SEMI-FINISHED PRODUCTS TO AVOID LINTING STUCK ONTO THE PRODUCTS DURING PRODUCT'S TRANSFER. BASED ON THE INVESTIGATION, THERE WERE NO ABNORMALITIES FOUND DURING PRODUCTION OR IN DHR. THEREFORE, 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 THAT DURING A CARDIAC PROCEDURE THERE WAS A LARGE AMOUNT OF LINT ON THE BLUE TOWELS PWTB04-STM FROM ANGIO PACK, SAN2ARAKPI. THE TOWELS WERE LAID ON THE PATIENT DRAPE TO ABSORB FLUID. LINT WAS FOUND ON INSTRUMENT WIRES. THERE WAS A 60 SECOND DELAY TO REMOVE THE LINT WITH NO PATIENT INJURY. NO CLINICAL DATA OR PATIENT DEMOGRAPHICS WERE PROVIDED AFTER NUMEROUS ATTEMPTS TO OBTAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631106 PACK ANGIO CVL KNPW (RAKPH)816 ANGIOGRAPHY/ANGIOPLASTY KIT OEQ MEX03 MEXICO-JUAREZ PRESOURCE SAN2ARAKPI 563481 10888439854916

    Patients

    Seq Age Sex Outcome Treatment
    1 Other