BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURO-SP-1/2X1/2"-STRL 20/CS

    MDR report key: 22106643 · Received May 29, 2025

    Report

    Report Number
    1060680-2025-00038
    Event Type
    Malfunction
    Date Received
    May 29, 2025
    Date of Event
    February 20, 2025
    Report Date
    August 28, 2025
    Manufacturer
    MEDSORB DOMINICANA, S.A.
    Product Code
    EFQ
    UDI-DI
    50749756037247
    PMA / PMN Number
    K791871
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DISTRIBUTING FACILITY REPORTED, "NEURURGICAL SPONGE IS NOT RADIOLUCENT DURING X-RAY TAKING" 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. ALL RADIOLUCENT PIECES WERE ATTACHED AND NO ISSUES 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 THERE WAS NO EVIDENCE OF IMPROPER ASSEMBLY, MISSING COMPONENTS, OR INADEQUATE RADIOPAQUE MATERIAL APPLICATION. INCOMING INSPECTION PAPERWORK WAS ALSO REVIEWED AND FOUND TO BE TESTED IN ACCORDANCE WITH THE ASTM F640-20 STANDARD TEST METHODS FOR DETERMINING RADIOPACITY FOR MEDICAL USE. THE CERTIFICATE OF CONFORMANCE RECEIVED FROM THE SUPPLIER CONFIRMS THE PASSING RESULT OF THIS TESTING. THIS SPONGE SIZE (1/2" X 1/2") IS AMONG THE SMALLEST OFFERED, MAKING IT MORE PRONE TO OCCLUSION OR LOW CONTRAST IN HIGH-DENSITY TISSUE OR SUBOPTIMAL IMAGING POSITIONS. ROOT CAUSE: BECAUSE THE SAMPLE WAS UNAVAILABLE FOR RETURN AND NO ISSUES WERE FOUND IN THE PRODUCTION RECORDS, THE ROOT CAUSE WAS UNABLE TO BE DETERMINED. CORRECTIVE AND PREVENTIVE ACTIONS: BECAUSE THE ROOT CAUSE WAS UNABLE TO BE DETERMINED, NO CORRECTIVE OR PREVENTIVE ACTIONS WERE TAKEN. 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, "NEURURGICAL SPONGE IS NOT RADIOLUCENT DURING X-RAY TAKING." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE BUT HAS NOT YET BEEN RECEIVED. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WILL BE ISSUED TO THE SUPPLIER/MANUFACTURER. 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, "NEURURGICAL SPONGE IS NOT RADIOLUCENT DURING X-RAY TAKING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625655 NEURO-SP-1/2X1/2"-STRL 20/CS GAUZE/SPONGE, INTERNAL EFQ MEDSORB DOMINICANA, S.A. 30-054 22082537 50749756037247

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown