BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OR TOWEL, BLUE, X-RAY DETECT., GEOMED, STERILE, 4/PK, 20PK/CS

    MDR report key: 19929609 · Received August 7, 2024

    Report

    Report Number
    1060680-2023-00002
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    February 23, 2023
    Report Date
    June 1, 2023
    Manufacturer
    US MEDCO INC.
    Product Code
    FRL
    UDI-DI
    50749756677061
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED ON 2/23/2023 THAT, "SR (B)(6) ADVISED THAT THE VA ACCOUNT HAS ORDERED (B)(4) CASE OF ITEM DT04-B-MA, RECEIVED (B)(4), AND NEED TO RETURN (B)(4) CASE BECAUSE IT IS A SAFETY HAZARD. THE TOWELS ARE NOT DELINTED AND CANNOT BE USED IN SURGERIES DUE TO THE LINT IN THE TOWEL". THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WILL BE REQUESTED FROM US MEDCO INC. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT ONCE MORE INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS REQUESTED MULTIPLE TIMES, BUT NEVER RETURNED TO DEROYAL INDUSTRIES FOR TESTING. DEROYAL INDUSTRIES REVIEWED FAILURE MODES AND EFFECTS ANALYSIS (FMEA) AND TO SEE IF THERE WERE ANY CORRECTIVE ACTIONS AND PREVENTIVE ACTIONS (CAPAS) FOR THIS ITEM. NO ISSUES WERE FOUND WITH EITHER OF THESE REVIEWS. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS REQUESTED FROM US MEDCO INC. US MEDCO INC. RESPONDED TO THE REQUEST STATING THAT BECAUSE THERE WAS NO LOT NUMBER GIVEN OR NO SAMPLE RETURNED, THEY COULD NOT DO AN INVESTIGATION OR GIVE ANY FURTHER INFORMATION. THEREFORE, BECAUSE WITH NO LOT NUMBER, NO SAMPLE RETURNED, AND NO COMPLETED SCAR, THE ROOT CAUSE OF THE ISSUE WAS UNABLE TO BE DETERMINED. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS FOR THIS ITEM AND ISSUE. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    ORDERED (B)(4) CASE OF ITEM DT04-B-MA, RECEIVED (B)(4)\, AND NEED TO RETURN (B)(4) CASE BECAUSE IT IS A SAFETY HAZARD. THE TOWELS ARE NOT DELINTED AND CANNOT BE USED IN SURGERIES DUE TO THE LINT IN THE TOWEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220548 OR TOWEL, BLUE, X-RAY DETECT., GEOMED, STERILE, 4/PK, 20PK/CS FIBER, MEDICAL, ABSORBENT FRL US MEDCO INC. DT04-B-M 50749756677061

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown