BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPONGE NEURO 10 PATTIES XRAY, .5 X .5 

    MDR report key: 23201358 · Received October 2, 2025

    Report

    Report Number
    1060680-2025-00051
    Event Type
    Malfunction
    Date Received
    October 2, 2025
    Date of Event
    September 16, 2025
    Report Date
    December 18, 2025
    Manufacturer
    MEDSORB DOMINICANA, S.A.
    Product Code
    EFQ
    PMA / PMN Number
    K791871
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DI0STRIBUTING FACILITY REPORTED, "HAD THE GREEN STRIPE SEPARATE FROM THE SPONGE. FULL GREEN STRIPE ACCOUNTED FOR, AND BOTH THE SPONGE AND THE STRIPE WERE REMOVED FROM THE FIELD. WAS THERE INJURY? NO, BUT PRODUCT FAILURE HAS THE POSSIBILITY FOR ERROR." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, AND IT WAS RECEIVED ON 10/09/2025. UPON INSPECTION THE ISSUE WAS CONFIRMED AS THE GREEN X-RAY ELEMENT WAS OBSERVED UNATTACHED. AN INVENTORY CHECK WAS UNABLE TO BE PERFORMED AS THERE WAS NOT ANY IN STOCK. BECAUSE THIS IS A PURCHASED PART, DEROYAL DID NOT HAVE A RISK ANALYSIS TO REVIEW. A COMPLAINT TO SALES RATIO WAS CONDUCTED BETWEEN SEPTEMBER 2023 TO SEPTEMBER 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 REVIEWED A PREVIOUS SIMILAR COMPLAINT. 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: BECAUSE THE SAMPLE WAS NOT ABLE TO BE DETERMINED, THE SPECIFIC ROOT CAUSE WAS NOT ABLE TO BE DETERMINED, HOWEVER, WITH THE PREVIOUS COMPLAINT, A POTENTIAL ROOT CAUSE WOULD BE 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. CORRECTIVE AND PREVENTIVE ACTIONS: CORRECTIVE AND PREVENTIVE ACTIONS WERE TAKEN ON THE PREVIOUS COMPLAINT AND WOULD ALSO APPLY TO THIS POTENTIAL ROOT CAUSE. THIS PREVIOUS COMPLAINT NUMBER (B)(4) AND SUBMITTED WITH MDR # 1060680-2025-00004. 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 DISTRIBUTING FACILITY REPORTED, "HAD THE GREEN STRIPE SEPARATE FROM THE SPONGE. FULL GREEN STRIPE ACCOUNTED FOR, AND BOTH THE SPONGE AND THE STRIPE WERE REMOVED FROM THE FIELD. WAS THERE INJURY? NO, BUT PRODUCT FAILURE HAS THE POSSIBILITY FOR ERROR." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, BUT IT HAS NOT YET BEEN RECEIVED. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WILL BE ISSUED TO THE SUPPLIER, MEDSORB DOMINICANA, S.A. 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 DISTRIBUTING FACILITY REPORTED, "HAD THE GREEN STRIPE SEPARATE FROM THE SPONGE. FULL GREEN STRIPE ACCOUNTED FOR, AND BOTH THE SPONGE AND THE STRIPE WERE REMOVED FROM THE FIELD. WAS THERE INJURY? NO, BUT PRODUCT FAILURE HAS THE POSSIBILITY FOR ERROR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18114 SPONGE NEURO 10 PATTIES XRAY, .5 X .5  GAUZE/SPONGE, INTERNAL EFQ MEDSORB DOMINICANA, S.A. 30-054NS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown