BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CCASC LAPAROTOMY PACK

    MDR report key: 23815362 · Received December 16, 2025

    Report

    Report Number
    3005011024-2025-00016
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    October 1, 2025
    Report Date
    December 18, 2025
    Manufacturer
    DEROYAL INDUSTRIES, INC..
    Product Code
    LRO
    UDI-DI
    00749756364430
    PMA / PMN Number
    K842648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY THROUGH A MEDWATCH, "HAIR ON ASEPTO BULB IN LAPAROTOMY PACK."

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED, "HAIR ON ASEPTO BULB IN LAPAROTOMY PACK." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE AND RECEIVED IT ON 12/16/2025. UPON INSPECTION, THE ISSUE WAS CONFIRMED. THE WORK ORDER WAS REVIEWED FOR THE LOT ON THE COMPLAINT AND NO ISSUES WERE FOUND. NO INVENTORY WAS ABLE TO BE INSPECTED AS THE LAFOLLETTE BRANCH PLANT HAS CLOSED AND NO INVENTORY IS AVAILABLE OR BEING MADE. A PREVIOUS CORRECTIVE AND PREVENTATIVE ACTION (CAPA) WAS CLOSED IN AUGUST FOR SIMILAR ISSUES. ROOT CAUSE: NO ISSUES WERE FOUND WITHIN THE WORK ORDER. THEREFORE, BASED ON THAT AND THE PREVIOUS CAPA, THE TRUE ROOT CAUSE WAS UNABLE TO BE DETERMINED. POSSIBLE ROOT CAUSES MAY HAVE BEEN INATTENTION TO DETAIL WHILE DOING VISUAL INSPECTION OF COMPONENTS PLACED WITHIN THE PACK. VENDOR RELATED CONCEALED WITHIN FOLDS OF THE COMPONENTS. INCREASED MOVEMENT WHERE THE RAW MATERIALS ARE LOCATED. CORRECTIVE AND PREVENTIVE ACTIONS. SEVERAL CORRECTIVES WERE TAKEN INCLUDING: GOWNING REINFORCEMENT-NEW SUPPLIER OF HAIR NETS AND BEARD COVERS, HEIGHTENED INSPECTION- MANAGEMENT HAS DEVELOPED A PROCESS FOR BIN COUNTING, AND CLEANING AND SANITATION-FILTRATION SYSTEM FOR CLEAN ROOMS CHANGED AND CURTAINS WERE INSTALLED FOR WINDOWS BETWEEN MANUFACTURING AND BOXING DEPARTMENTS TO PREVENT CROSS-CONTAMINATION. 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 INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    A USER FACILITY THROUGH A MEDWATCH, "HAIR ON ASEPTO BULB IN LAPAROTOMY PACK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2281641 CCASC LAPAROTOMY PACK GENERAL SURGERY TRAY LRO DEROYAL INDUSTRIES, INC.. 89-10558 62541646 00749756364430

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown