BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA INVASIVE RADIOLOGY (IRPRB)503

    MDR report key: 11957583 · Received June 8, 2021

    Report

    Report Number
    1423537-2021-00638
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    May 11, 2021
    Report Date
    June 8, 2021
    Manufacturer
    SC003 SC-FORT MILL
    Product Code
    OEQ
    UDI-DI
    10887488972428
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE SUPPLIER INVESTIGATION, THE DEVICE HISTORY RECORD REVIEW DID NOT INDICATE ANY EXCEPTION THAT COULD LEAD TO THE REPORTED INCIDENT. NO SAMPLE WAS RETURNED FOR INVESTIGATION. ACCORDING TO SUPPLIER, OPERATING ROOM TOWEL IS MADE OF COTTON, SO LINT IS BORN AND INEVITABLE. THE INTENDED USE OF OPERATING ROOM TOWEL IS USED FOR APPLYING MEDICATION OR ABSORBING SMALL AMOUNTS OF BODY FLUIDS FROM A PATIENT'S BODY SURFACE. SUPPLIER HAD WORKED WITH CARDINAL 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), 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 AND ALL LINTING TEST DATA WERE WITHIN THE ACCEPTABLE RANGE. THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. 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 THE BLUE TOWEL PWTB03-STMA FROM THE INVASIVE RADIOLOGY PACK SAN30IRPRC WAS USED TO WIPE DOWN THE GUIDEWIRE AND A LOT OF LINT WAS STICKING TO THE GUIDEWIRE DURING AN ANGIOGRAPHY. A DELAY OF 5 MINUTES WAS REPORTED TO REPLACE THE TOWELS. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853170 VA INVASIVE RADIOLOGY (IRPRB)503 ANGIOGRAPHY/ANGIOPLASTY KIT OEQ SC003 SC-FORT MILL SAN30IRPRC 582816 10887488972428

    Patients

    Seq Age Sex Outcome Treatment
    1 Other