BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURO SPG-1X3"-STERILE- 20/CS

    MDR report key: 22029251 · Received May 15, 2025

    Report

    Report Number
    1060680-2025-00029
    Event Type
    Malfunction
    Date Received
    May 15, 2025
    Date of Event
    May 13, 2025
    Report Date
    September 2, 2025
    Manufacturer
    MEDSORB DOMINICANA, S.A.
    Product Code
    EFQ
    UDI-DI
    50749756037780
    PMA / PMN Number
    K791871
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED, "PACK OF THE NEURO SPONGES WAS OPENED DURING CASE AND COUNTED. COUNT WAS 11, RECOUNTED, AND COUNT WAS 11 AGAIN. REMOVED FROM THE FIELD." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, BUT IT WAS NOT ABLE TO BE RETURNED. DEROYAL REVIEWED THE WORK ORDER OF THE DEVICE AND NO ISSUES WERE FOUND. AN INVENTORY CHECK WAS ALSO PERFORMED ON ONE CASE OF THE NEUROSPONGES. NO DISCREPANCIES WERE FOUND. BECAUSE THIS IS A PURCHASED PART, DEROYAL DID NOT HAVE A RISK ANALYSIS TO REVIEW. A COMPLAINT TO SALES RATIO WAS CONDUCTED BETWEEN (B)(6) 2023 TO (B)(6) 2025 AND FOUND TO BE 0.002%. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WILL BE ISSUED TO THE SUPPLIER, MEDSORB DOMINICANA, S.A. THE SUPPLIER REVIEWED THE DEVICE HISTORY RECORD (DHR) AND MANUFACTURING PROCESS OF THE NEURO SPONGES. THE WORK ORDERS FOR THE LOT PROVIDED WERE REVIEWED AND NO FURTHER NONCONFORMING PRODUCT WAS FOUND. THE PRODUCT WAS NOT RETURNED AND THERE WAS NO WORK IN PROGRESS TO REVIEW. WHILE THE ROOT CAUSE WAS NOT SPECIFICALLY ABLE TO BE CONFIRMED BECAUSE THE SAMPLE WAS NOT RETURNED, IT WAS LIKELY THAT THIS MALFUNCTION OCCURRED BECAUSE OF AN UNDETECTED OVERFILL CAUSED BY HUMAN ERROR DURING MANUAL COUNTING. THE SUPPLIER REVIEWED TRAINING RECORDS AND ALL EMPLOYEES WERE ADEQUATELY TRAINED, HOWEVER THE ISSUE WAS MOST LIKELY DUE TO HUMAN ERROR IN THE COUNTING. ROOT CAUSE: WHILE THE ROOT CAUSE WAS NOT SPECIFICALLY ABLE TO BE CONFIRMED BECAUSE THE SAMPLE WAS NOT RETURNED, IT WAS LIKELY THAT THIS MALFUNCTION OCCURRED BECAUSE OF AN UNDETECTED OVERFILL CAUSED BY HUMAN ERROR DURING MANUAL COUNTING. CORRECTIVE AND PREVENTIVE ACTIONS: BECAUSE THE ROOT CAUSE WAS UNABLE TO BE CONFIRMED, THE ACTIONS TAKEN WERE BASED ON A POTENTIAL ROOT CAUSE. THIS INCLUDED REFRESHER TRAINING FOR ALL RELEVANT PERSONNEL TO EMPHASIZE COUNTING STEPS AND VISUAL AIDS. 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.

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED, "PACK OF THE NEURO SPONGES WAS OPENED DURING CASE AND COUNTED. COUNT WAS 11, RECOUNTED, AND COUNT WAS 11 AGAIN. REMOVED FROM THE FIELD." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE BUT IT HAS NOT BEEN RECEIVED. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WILL BE ISSUED TO THE SUPPLIER. 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.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED, "PACK OF THE NEURO SPONGES WAS OPENED DURING CASE AND COUNTED. COUNT WAS 11, RECOUNTED, AND COUNT WAS 11 AGAIN. REMOVED FROM THE FIELD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98700 NEURO SPG-1X3"-STERILE- 20/CS GAUZE/SPONGE, INTERNAL EFQ MEDSORB DOMINICANA, S.A. 30-060 23071617 50749756037780

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown