BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURO SPNG-1/2X3"-STRL- 20/CS

    MDR report key: 21193131 · Received January 20, 2025

    Report

    Report Number
    1060680-2025-00001
    Event Type
    Malfunction
    Date Received
    January 20, 2025
    Date of Event
    January 2, 2025
    Report Date
    April 9, 2025
    Manufacturer
    MEDSORB DOMINICANA, S.A.
    Product Code
    EFQ
    PMA / PMN Number
    K791871
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED, "NOTICED A SMALL PIECE OF COTTONOID THAT DETACHED DUE TO THE WAY IT WAS CUT BY THE MANUFACTURER AND HAD THE POTENTIAL TO BE LEFT IN THE PATIENT." DEROYAL INDUSTRIES REQUESTED RETURN OF THE DEVICE, HOWEVER IT WAS UNAVAILABLE FOR RETURN. A PICTURE OF THE DEVICE WAS PROVIDED. INFORMATION WAS CORRECTED FOR PRODUCT CODE TO BE EFQ AND FOR THE 510K TO BE K791871 AS THESE WERE INPUT INCORRECTLY ON THE INITIAL REPORT. DEROYAL INDUSTRIES, INC. REVIEWED WORK ORDER FOR 236 CASES OF PRODUCT AND FOUND NO ISSUES. A REVIEW OF ANY CORRECTIVE AND PREVENTIVE ACTIONS (CAPAS) WAS CONDUCTED AND NO APPLICABLE CAPAS WERE FOUND. AN INVENTORY CHECK WAS NOT ABLE TO BE PERFORMED AS THERE WAS NO INVENTORY ON HAND. THIS IS ALSO A PURCHASED PRODUCT SO NO RISK ANALYSIS WAS REVIEWED BY DEROYAL. A COMPLAINT TO SALES RATIO WAS CONDUCTED FROM JANUARY 2023 TO JANUARY 2025 AND WAS FOUND TO BE (B)(4). A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE SUPPLIER AND RETURNED. THE SUPPLIER CONDUCTED A DEVICE HISTORY RECORD (DHR) REVIEW, INTERVIEWS WITH STAFF AND SUPERVISORS, AND A REVIEW OF MATERIAL SPECIFICATIONS AND INCOMING INSPECTION FOR NEURO MATERIAL. ROOT CAUSE: THE ROOT CAUSE WAS NOT ABLE TO BE DETERMINED. THE REVIEW OF THE DHR AND MANUFACTURING PROCESSES DID NOT SHOW ANY ISSUES TO SUGGEST THAT MANUFACTURING WAS THE CAUSE OF THE ISSUE. INSPECTIONS THROUGHOUT THE PROCESS AT THE RAW MATERIAL LEVEL, IN-PROCESS PRODUCTION, AND FINISHED GOODS CONFIRMED THE MATERIAL INTEGRITY WAS MAINTAINED. ADDITIONALLY, A REVIEW OF INCOMING INSPECTION DOCUMENTS AND MATERIAL SPECIFICATIONS SHOWED NO CHANGES IN THE RAW MATERIAL. POTENTIAL ROOT CAUSE: POTENTIAL CAUSES MAY BE RELATED TO END-USER HANDLING, EXCESSIVE HANDLING, OR CONTACT WITH SHARP INSTRUMENTS DURING USE WHICH COULD HAVE AFFECTED THE NON-WOVEN MATERIAL. HOWEVER, THESE ARE JUST POTENTIAL ROOT CAUSES AS THIS INFORMATION COULD NOT BE CONFIRMED. CORRECTIVE AND PREVENTIVE ACTIONS: BECAUSE NO ROOT CAUSE COULD BE DETERMINED, NO CORRECTIVE OR PREVENTIVE ACTIONS HAVE TAKEN PLACE. 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, "NOTICED A SMALL PIECE OF COTTONOID THAT DETACHED DUE TO THE WAY IT WAS CUT BY THE MANUFACTURER AND HAD THE POTENTIAL TO BE LEFT IN THE PATIENT." DEROYAL INDUSTRIES REQUESTED RETURN OF THE DEVICE, HOWEVER IT WAS UNAVAILABLE FOR RETURN. A PICTURE OF THE DEVICE WAS PROVIDED. 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, "NOTICED A SMALL PIECE OF COTTONOID THAT DETACHED DUE TO THE WAY IT WAS CUT BY THE MANUFACTURER AND HAD THE POTENTIAL TO BE LEFT IN THE PATIENT. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985416 NEURO SPNG-1/2X3"-STRL- 20/CS GAUZE/SPONGE, INTERNAL EFQ MEDSORB DOMINICANA, S.A. 30-057 24092500

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown