BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHALTONI IR PACK (SRUTA)629

    MDR report key: 10103420 · Received May 29, 2020

    Report

    Report Number
    1423537-2020-00464
    Event Type
    Malfunction
    Date Received
    May 29, 2020
    Date of Event
    April 29, 2020
    Report Date
    May 29, 2020
    Manufacturer
    MEX03 MEXICO-JUAREZ PRESOURCE
    Product Code
    OIO
    UDI-DI
    10888439526622
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE SUPPLIER INVESTIGATION, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS A LOT NUMBER WAS NOT PROVIDED. SUPPLIER REVIEWED THE RECORDS OVER THE LAST 2 YEARS AND NO ABNORMAL SITUATION WAS FOUND. NO SAMPLE WAS RETURNED FOR INVESTIGATION, ONLY A PHOTO WAS PROVIDED SHOWING BLUE LINT. ACCORDING TO THE SUPPLIER, THE OR TOWEL IS MADE OF COTTON, SO COTTON FIBER IS A NORMAL CHARACTERISTIC. SUPPLIER CONTINUOUSLY IS 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, 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 THAT 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

    CUSTOMER REPORTED THAT THE BLUE ,COTTON OR TOWELS PWTB04-STM, FROM THE IR PACK SAN44SRUTB ARE SHEDDING FIBERS ONTO VARIOUS WIRES AND CATHETERS DURING AN INTRACRANIAL EMBOLIZATION. THE TOWELS WERE USED FOR FLUID ABSORPTION OUTSIDE THE DRAPE. THERE WAS NO INJURY OR DELAY. NO PATIENT DEMOGRAPHICS WERE PROVIDED UPON REQUEST. CARDINAL HEALTH IS FILING A REPORT FOR MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563651 SHALTONI IR PACK (SRUTA)629 RADIOGRAPHIC CONTRAST TRAY OIO MEX03 MEXICO-JUAREZ PRESOURCE SAN44SRUTB UNKNOWN 10888439526622

    Patients

    Seq Age Sex Outcome Treatment
    1 Other