CMC LAPAROTOMY PACK

Description of Event or Problem

A USER FACILITY REPORTED, "HAIR ON MEDICATION SHEET IN LAPAROTOMY PACK."

Additional Manufacturer Narrative

A USER FACILITY REPORTED, "HAIR ON MEDICATION SHEET IN LAPAROTOMY PACK." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, BUT IT WAS NOT RECEIVED. DUE TO A TREND OF SIMILAR COMPLAINTS FROM JANUARY 2025, AN INVESTIGATION WAS LAUNCHED TO ENSURE ANY AND ALL CORRECTIVE ACTIONS WERE TAKEN TO MITIGATE THE ISSUE. THROUGHOUT THE INVESTIGATION, ASSEMBLY PROCESSES WERE REVIEWED AS WELL AS PRODUCTION RECORDS. SUPPLIERS WERE ALSO CONSULTED AND INTERVIEWED TO DETERMINE ANY ISSUES ON THE VENDOR SIDE. ROOT CAUSE: WHILE THE TRUE ROOT CAUSE OF DEBRIS/PARTICULATE & HAIR CONTAMINATION WITHIN THE PACKS 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: THERE WAS AN INCREASE TO THE GOWNING REINFORCEMENT INCLUDING A NEW SUPPLIER OF HAIR NETS AND BEARD COVERS. THE FILTRATION SYSTEM FOR THE CLEAN ROOMS WAS CHANGED TO HELP WITH CLEANING AND SANITATION. CURTAINS FOR WINDOWS BETWEEN MANUFACTURING AND BOXING DEPARTMENTS WERE ALSO INSTALLED TO PREVENT CROSS-CONTAMINATION. INSPECTIONS WERE ALSO HEIGHTED WITH A NEWLY DEVELOPED PROCESS FOR BIN COUNTING. THIS PROCESS HELPS FOR PRE-COUNTING SMALL ITEMS AND THEREFORE INCREASING THE INSPECTION ON THESE ITEMS. 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.