BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 22029254 · Received May 15, 2025

    Report

    Report Number
    1060680-2025-00028
    Event Type
    Malfunction
    Date Received
    May 15, 2025
    Date of Event
    May 4, 2025
    Report Date
    September 2, 2025
    Manufacturer
    MEDSORB DOMINICANA, S.A.
    Product Code
    EFQ
    UDI-DI
    00749756037785
    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, "OPENED PACK OF NEURO SPONGES 1 IN X 3 IN AND LATER FOUND FLOATING PIECE UNATTACHED TO ANY SPONGES FOUND BY SURGEON IN PATIENT'S RIGHT NASAL CAVITY VIA ENDOSCOPE DURING SURGERY. PIECE WAS TAKEN OUT AND THE ENTIRE PACK WAS TAKEN OFF THE STERILE FIELD. REPORTED TO CHARGE NURSE AND MANAGER." 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 MAY 2023 TO MAY 2025 AND FOUND TO BE (B)(4). 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. DUE TO THE PREVIOUS COMPLAINT, IT WAS NOTICED THAT WHEN MATERIAL THICKNESS VARIATIONS WOULD OCCUR, THE PRODUCTION ASSOCIATES WOULD ADJUST THE HORN CLEARANCE BUT FAIL TO VERIFY IF THE ADJUSTMENT WAS WITHIN THE SPECIFIED PARAMETERS. WITHIN THE PREVIOUS COMPLAINT, CORRECTIVE ACTIONS WERE TAKEN, BUT THIS LOT WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF THOSE ACTIONS. ROOT CAUSE: THE INVESTIGATION REVEALED THAT WHEN MATERIAL THICKNESS VARIES, PERSONNEL MAKE HORN CLEARANCE CHANGES WITHOUT VALIDATING THE ADJUSTMENTS AFTER. THE WORK INSTRUCTIONS DID NOT INCLUDE THAT PRODUCTION ASSOCIATES VERIFY THE HORN CLEARANCE AFTER THE ADJUSTMENT AT THE TIME THE LOT WAS MANUFACTURED. CORRECTIVE AND PREVENTIVE ACTIONS: ACTIONS WERE INITIATED WITHIN THE PREVIOUS COMPLAINT, BUT APPLY TO THIS COMPLAINT AS WELL. THESE ACTIONS INCLUDED NEW HORNS WITH WELDER TIPS THAT PROVIDE MORE STABILITY TO THE MATERIAL. ADDITIONALLY, WORK INSTRUCTIONS WERE UPDATED TO MANDATE THE VERIFICATION OF THE DISTANCE BETWEEN THE HORN AND THE ANVIL. WITH COMPLAINT SPECIFICALLY, A RETRAINING WAS CONDUCTED FOR ALL THE OPERATORS AND SUPERVISORS ON CORRECT WELD SETUP. 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, "OPENED PACK OF NEURO SPONGES 1 IN X 3 IN AND LATER FOUND FLOATING PIECE UNATTACHED TO ANY SPONGES FOUND BY SURGEON IN PATIENT'S RIGHT NASAL CAVITY VIA ENDOSCOPE DURING SURGERY. PIECE WAS TAKEN OUT AND THE ENTIRE PACK WAS TAKEN OFF THE STERILE FIELD. REPORTED TO CHARGE NURSE AND MANAGER." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, BUT IT HAS NOT YET BEEN RETURNED. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WILL BE SENT TO THE SUPPLIER. THE INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE A FOLLOW-UP REPORT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED, "OPENED PACK OF NEURO SPONGES 1 IN X 3 IN AND LATER FOUND FLOATING PIECE UNATTACHED TO ANY SPONGES FOUND BY SURGEON IN PATIENT'S RIGHT NASAL CAVITY VIA ENDOSCOPE DURING SURGERY. PIECE WAS TAKEN OUT AND THE ENTIRE PACK WAS TAKEN OFF THE STERILE FIELD. REPORTED TO CHARGE NURSE AND MANAGER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98703 NEURO SPG-1X3"-STERILE- 20/CS GAUZE/SPONGE, INTERNAL EFQ MEDSORB DOMINICANA, S.A. 30-060 23071617 00749756037785

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown