BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURO SPGS-3/4X6"-20/C

    MDR report key: 22519939 · Received July 16, 2025

    Report

    Report Number
    1060680-2025-00042
    Event Type
    Malfunction
    Date Received
    July 16, 2025
    Date of Event
    July 9, 2025
    Report Date
    November 6, 2025
    Manufacturer
    MEDSORB DOMINICANA, S.A.
    Product Code
    EFQ
    UDI-DI
    00749756037761
    PMA / PMN Number
    K791871
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED, "NEURO STRIP SPONGE HAD 11 STRIPS INSTEAD OF 10 ONLY." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE BUT IT WAS UNAVAILABLE TO BE RETURNED. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WILL BE ISSUED TO THE SUPPLIER, (B)(4). THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW UP REPORT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED, "NEURO STRIP SPONGE HAD 11 STRIPS INSTEAD OF 10 ONLY." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE BUT IT WAS UNAVAILABLE TO BE RETURNED. DEROYAL REVIEWED WORK ORDERS WITH THE LOT NUMBER PROVIDED. NO DISCREPANCIES WERE NOTED THAT WOULD HAVE CONTRIBUTED TO THIS ISSUE. AN INVENTORY CHECK WAS ALSO PERFORMED ON A CASE OF THE PRODUCT IN THE DISTRIBUTION FACILITY AND NO ISSUES WERE FOUND. A COMPLAINT TO SALES RATIO WAS CONDUCTED FROM JULY 2023 TO JULY 2025 AND WAS FOUND TO BE 0.0089%. THIS PRODUCT ARRIVES TO DEROYAL ALREADY PACKAGED, THE QUALITY SPECIALIST SET AN ALERT ON THESE ITEMS TO CHECK FOR THESE ISSUES WHEN THE NEXT SHIPMENT ARRIVES TO DEROYAL. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE SUPPLIER, MEDSORB DOMINICANA. MEDSORB REVIEWED THE DEVICE HISTORY RECORD (DHR), COMPLAINT RECORDS, AND MANUFACTURING PROCESS OF THE NEURO SPONGES. ALL PRODUCTION ASSOCIATES WERE NOTIFIED OF THE ISSUE TO RAISE AWARENESS. DURING THE INVESTIGATION IT WAS DETERMINED THAT ALL PROCEDURES, TRAINING, AND RECORDS WERE COMPLYING. NO DEVIATIONS WERE FOUND IN THE PACKING WORK INSTRUCTION OR DHR. HOWEVER, BECAUSE THE PROCESS INVOLVES MANUAL COUNTING OF STRIPS PRIOR TO POUCH SEALING, THE MOST LIKELY CAUSE IS HUMAN ERROR DURING THE COUNTING STEP. ROOT CAUSE: THE EXACT ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED, AS THE WORK INSTRUCTION, DHR, AND TRAINING RECORDS WERE FOUND ADEQUATE, AND NO DISCREPANCIES WERE IDENTIFIED DURING THE INVESTIGATION. POTENTIAL ROOT CAUSE: WHILE THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED, THERE IS A POTENTIAL ROOT CAUSE OF HUMAN ERROR DURING THE COUNTING STEP OF THE NEURO STRIPS. CORRECTIVE AND PREVENTIVE ACTIONS: ALL PRODUCTION ASSOCIATES WERE REMINDED OF THE IMPORTANCE OF COUNT VERIFICATION PRIOR TO SEALING THE POUCH. A REFRESHER TRAINING ON THE PACKING INSTRUCTIONS AND THE REQUIRED COUNT PER POUCH WAS ALSO PROVIDED. THE QUALITY CONTROL INSPECTOR WILL ALSO CONDUCT PERIODIC SPOT CHECKS DURING PACKING OPERATIONS TO VERIFY CORRECT POUCH COUNTS AND REINFORCE ADHERENCE TO THE PROCEDURE. THIS ADDITIONAL OVERSIGHT WILL HELP PREVENT RECURRENCE AND ENSURE CONSISTENT COMPLIANCE WITH COUNTING REQUIREMENTS. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS AROUND 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

    A USER FACILITY REPORTED, "NEURO STRIP SPONGE HAD 11 STRIPS INSTEAD OF 10 ONLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161921 NEURO SPGS-3/4X6"-20/C GAUZE/SPONGE, INTERNAL EFQ MEDSORB DOMINICANA, S.A. 30-303 24112887 00749756037761

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown