CCASC LAPAROTOMY PACK

Additional Manufacturer Narrative

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

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

Additional Manufacturer Narrative

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