BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURO SPG-1X1"-STERILE- 20/CS

    MDR report key: 21424552 · Received February 20, 2025

    Report

    Report Number
    1060680-2025-00015
    Event Type
    Malfunction
    Date Received
    February 20, 2025
    Date of Event
    February 10, 2025
    Report Date
    April 24, 2025
    Manufacturer
    MEDSORB DOMINICANA, S.A.
    Product Code
    EFQ
    UDI-DI
    00749756037419
    PMA / PMN Number
    K791871
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED THAT THEY HAVE RECEIVED INFORMATION FROM ONE OF OUR OPERATING ROOMS THAT THEY ARE HAVING ISSUES WITH THE RADIOPAQUE STRIP SEPARATING FROM THE NEURO SPONGE FROM THE SPONGES INCLUDED IN ONE OF OUR CUSTOM PACKS WE RECEIVE FROM CARDINAL. AS I MENTIONED, WE HAVE A TEAM WORKING WITH CARDINAL BUT I WANTED TO GET THIS INFORMATION TO YOU AS WELL. THERE HAVE BEEN 3 INCIDENTS, THE FIRST WAS A 1X1, THE SECOND AND THIRD THEY ARE LOOKING TO GET MORE INFORMATION ON. DEROYAL INDUSTRIES REQUESTED RETURN OF THE DEVICE, HOWEVER IT WAS UNAVAILABLE FOR RETURN. 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. 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 THAT DEROYAL INDUSTRIES JUST DISTRIBUTES SO NO RISK ANALYSIS WAS REVIEWED BY DEROYAL. (B)(4). A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE MANUFACTURER AND RETURNED. THE SUPPLIER CONDUCTED A DEVICE HISTORY RECORD (DHR) REVIEW, INTERVIEWS WITH STAFF AND SUPERVISORS, AND A REVIEW OF MANUFACTURING PROCESSES. ROOT CAUSE: DURING THE INVESTIGATION, IT WAS DETERMINED THAT THE OPERATOR DID NOT CONDUCT PERIODIC INSPECTIONS OF THE WELDING PROCESS AS REQUIRED. IT WAS FOUND THAT THERE WAS A VARIANCE IN WELD DUE TO VARIANCE IN MATERIAL AND HORN TYPE (WELDER TIPS) USED DURING THE WELDING PROCESS. THE INVESTIGATION ALSO REVEALED THAT WHILE THE RISK OF X-RAY DETACHMENT IS NORMALLY A RISK, THERE IS A POTENTIALLY GREATER RISK THAT WAS INTRODUCED WITH THE RECENT ADDITION OF NEW EMPLOYEES TO THE X-RAY WELDING PROCESS THAT COULD RESULT FROM A LACK OF EXPERIENCE WITH THE MATERIAL, PROCESS, AND PRODUCT OF NEW HIRES. CORRECTIVE AND PREVENTIVE ACTIONS: A RISK ASSESSMENT WAS CONDUCTED TO IDENTIFY POTENTIAL RISKS ASSOCIATED WITH UNDECTED X-RAY WELD DEFECTS IN FINISHED GOOD PRODUCTS. A NEW FORM WAS CREATED TO REGISTER THE X-RAY WELDING PROCESS VERIFICATION EVERY 30 MINUTES DURING THE MANUFACTURING PROCESS AND TO REGISTER THE VERIFICATION OF THE HORN ANVIL DISTANCE USING THE FEELER GAUGE. PRODUCTION OPERATORS WERE TRAINED IN THE USE OF THE FEELER GAUGE AND WERE RETRAINED TO REINFORCE THE CRITICALITY OF THE PRODUCT WE ARE MANUFACTURING AND TO MONITOR/CHECK FOR PROPER X-RAY ATTACHMENT. MONITORING X-RAY ATTACHMENT SHALL BE DOCUMENTED IN THE NEW FORM WITH EVIDENCE OF VERIFICATION OF THE HORN ANVIL DISTANCE AND TO REGISTER THE VERIFICATION OF THE WELDING EVERY 30 MINUTES DURING THE WELDING PROCESS. SUBSEQUENTLY, NEW HORN TIPS WERE PURCHASED TO REPLACE THE CURRENT HORNS. THESE NEW HORNS PROVIDE MORE STABILITY TO THE WELD PROCESS; IF THERE IS ANY VARIANCE IN THE MATERIAL, THE WIDER HORNS SHALL KEEP THE MATERIAL FLAT AND STABLE. LASTLY, THE IN-PROCESS AND FINISHED GOOD INSPECTION PROCESS TO IMPROVE THE METHODS/FREQUENCY USED TO MONITOR X-RAY WELDS. 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 THAT THEY HAVE RECEIVED INFORMATION FROM ONE OF OUR OPERATING ROOMS THAT THEY ARE HAVING ISSUES WITH THE RADIOPAQUE STRIP SEPARATING FROM THE NEURO SPONGE FROM THE SPONGES INCLUDED IN ONE OF OUR CUSTOM PACKS WE RECEIVE FROM CARDINAL. AS I MENTIONED, WE HAVE A TEAM WORKING WITH CARDINAL BUT I WANTED TO GET THIS INFORMATION TO YOU AS WELL. THERE HAVE BEEN 3 INCIDENTS, THE FIRST WAS A 1X1, THE SECOND AND THIRD THEY ARE LOOKING TO GET MORE INFORMATION ON. DEROYAL INDUSTRIES REQUESTED RETURN OF THE DEVICE, HOWEVER IT WAS UNAVAILABLE FOR RETURN. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS 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, THAT THEY HAVE RECEIVED INFORMATION FROM ONE OF OUR OPERATING ROOMS THAT THEY ARE HAVING ISSUES WITH THE RADIOPAQUE STRIP SEPARATING FROM THE NEURO SPONGE FROM THE SPONGES INCLUDED IN ONE OF OUR CUSTOM PACKS WE RECEIVE FROM CARDINAL. AS I MENTIONED, WE HAVE A TEAM WORKING WITH CARDINAL BUT I WANTED TO GET THIS INFORMATION TO YOU AS WELL. THERE HAVE BEEN 3 INCIDENTS, THE FIRST WAS A 1X1, THE SECOND AND THIRD THEY ARE LOOKING TO GET MORE INFORMATION ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465665 NEURO SPG-1X1"-STERILE- 20/CS GAUZE/SPONGE, INTERNAL EFQ MEDSORB DOMINICANA, S.A. 30-059 00749756037419

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown