BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURO-SP-1/2X1/2"-STRL 20/CS30-054

    MDR report key: 19931675 · Received August 7, 2024

    Report

    Report Number
    1060680-2023-00004
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    April 3, 2023
    Report Date
    June 9, 2023
    Manufacturer
    MEDSORB DOMINICANA, S.A.
    Product Code
    EFQ
    UDI-DI
    00749756037242
    PMA / PMN Number
    K791871
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED ON 4/6/2023 THAT, "THE SPONGES WHEN BEING USED IN THE OR ARE STARTING TO COME APART WHEN USING ON THE PATIENT IN SURGERY. ESSENTIA HAS BEEN USING THESE FOR YEARS AND THIS IS THE FIRST TIME THIS HAS HAPPENED." THE SAMPLE HAS BEEN REQUESTED TO BE RETURNED TO DEROYAL, BUT HAS NOT YET ARRIVED. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WILL BE SENT TO 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 ONCE MORE INFORMATION IS CONCLUDED FROM THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    WHILE USER FACILITY LISTED THAT THE PRODUCT WAS AVAILABLE FOR RETURN, DEROYAL INDUSTRIES NEVER RECEIVED THE NEURO SPONGE FOR EVALUATION. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE SPONGE SUPPLIER MEDSORB DOMINICANA. MEDSORB REVIEWED THEIR DEVICE HISTORY RECORD AND FOUND THAT IT MET ALL ACCEPTANCE CRITERIA. THEY HAVE FOUND NO HISTORY THAT NEURO PATTIES SEPARATE FROM THE STRING PRIOR TO USE. MEDSORB HAS HAD NO CHANGES TO MATERIAL, PRODUCT DESIGN, MANUFACTURING PROCESSES, OR PROCEDURES. ROOT CAUSE: WAS STATED TO BE UNDETERMINED BY MEDSORB AS THEY FOUND NO EVIDENCE WITH THE SUBJECT LOT OR HISTORICALLY TO SUGGEST MANUFACTURING IS THE CAUSE OF THE REPORTED FAILURE. POTENTIAL ROOT CAUSE: WHILE MEDSORB DID NOT DETERMINE A ROOT CAUSE, OR POTENTIAL ROOT CAUSE OF THE EVENT, THEY DID STATE THAT THE STRING IS INTENDED FOR LOCATION OR COUNTING PURPOSES ONLY AND THAT THE IFU AND ACCOUNTABILITY WINDING CARD INCLUDES A SPECIFIC WARNING ABOUT THIS. CORRECTIVE AND PREVENTATIVE ACTIONS: BECAUSE NO ROOT CAUSE WAS ABLE TO BE DETERMINED, MEDSORB DID NOT TAKE ANY CORRECTIVE OR PREVENTATIVE ACTIONS. DEROYAL CALCULATED A COMPLAINT TO SALES RATIO FOR THIS PART. BETWEEN JUNE 2021 AND JUNE 2023, 9,270 CASES (185,400 EACHES) WERE SOLD AND TWO COMPLAINTS WERE RECORDED IN THAT SAME TIME FRAME. THIS CREATES A RATIO OF 0.000012 OR 0.0012%. 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.

    Description of Event or Problem · 0

    THE SPONGES WHEN BEING USED IN THE OR ARE STARTING TO COME APART WHEN USING ON THE PATIENT IN SURGERY. ESSENTIA HAS BEEN USING THESE FOR YEARS AND THIS IS THE FIRST TIME THIS HAS HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546217 NEURO-SP-1/2X1/2"-STRL 20/CS30-054 GAUZE/SPONGE, INTERNAL EFQ MEDSORB DOMINICANA, S.A. 30-054 21061898 00749756037242

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown