SAFETYSCALPEL ASMBD #3 FITMENT, #11 BLADE, BLUE NS

Additional Manufacturer Narrative

A DISTRIBUTING FACILITY REPORTED, "WE HAVE RECEIVED A CUSTOMER COMPLAINT REGARDING AN 11P RETRACTABLE SCALPEL WHERE THE OPERATOR HAS CUT THEMSELVES DUE TO THE BLADE PROTRUDING FROM THE HANDLE. IT STATES THAT THE WHEN THE OPERATOR WAS PLACING THE SCALPEL INTO THE PROCEDURE PACK, THE TIP WAS EXTENDED." DEROYAL INDUSTRIES REQUESTED RETURN OF THE DEVICE, BUT IT WAS NOT AVAILABLE FOR RETURN. PHOTOS OF THE DEVICE WERE PROVIDED. DEROYAL REVIEWED THE PURCHASE ORDER. DEROYAL RECEIVES THE BOX AND DOES NOT OPEN, BUT JUST APPLIES A LABEL. THERE IS ALSO A LABEL ON THE OUTSIDE OF THE BOX THAT INCLUDES A WARNING OF BLADES POTENTIALLY PROTRUDING DURING SHIPMENT. DEROYAL HAD NO INVENTORY ON HAND SO NO INVENTORY WAS INSPECTED. A COMPLAINT TO SALES RATIO WAS CONDUCTED FROM SEPTEMBER 2022 THROUGH SEPTEMBER 2024 AND FOUND TO BE (B)(4). A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS SENT TO THE SAFETY SCALPEL SUPPLIER AND RETURNED. THE SUPPLIER REVIEWED THE ASSEMBLY AREA AND INVENTORY AND FOUND NO ISSUES. IT WAS NOTED AFTER REVIEW THAT THIS ISSUE HAS NEVER BEEN FOUND INTERNALLY AND HAS ONLY EVER BEEN NOTED AFTER SHIPPING TRANSIT. ROOT CAUSE: BECAUSE THE DEVICE WAS NOT RETURNED FOR INVESTIGATION AND NO ISSUES COULD BE FOUND WITHIN THE MANUFACTURING OR ASSEMBLY PROCESSES, NO ROOT CAUSE WAS ABLE TO BE DETERMINED. CORRECTIVE OR PREVENTIVE ACTIONS: THE SUPPLIER CONTINUES TO TEST ALL IN PROCESS SAMPLES AND INSTALL WARNING LABELS ON BOXES TO NOTE POTENTIAL ISSUE DURING TRANSIT. 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

A DISTRIBUTING FACILITY REPORTED, "WE HAVE RECEIVED A CUSTOMER COMPLAINT REGARDING AN 11P RETRACTABLE SCALPEL WHERE THE OPERATOR HAS CUT THEMSELVES DUE TO THE BLADE PROTRUDING FROM THE HANDLE. IT STATES THAT THE WHEN THE OPERATOR WAS PLACING THE SCALPEL INTO THE PROCEDURE PACK, THE TIP WAS EXTENDED."

Additional Manufacturer Narrative

A DISTRIBUTING FACILITY REPORTED, "WE HAVE RECEIVED A CUSTOMER COMPLAINT REGARDING AN 11P RETRACTABLE SCALPEL WHERE THE OPERATOR HAS CUT THEMSELVES DUE TO THE BLADE PROTRUDING FROM THE HANDLE. IT STATES THAT THE WHEN THE OPERATOR WAS PLACING THE SCALPEL INTO THE PROCEDURE PACK, THE TIP WAS EXTENDED." DEROYAL INDUSTRIES REQUESTED RETURN OF THE DEVICE, BUT IT WAS NOT AVAILABLE FOR RETURN. PHOTOS OF THE DEVICE WERE PROVIDED. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS SENT TO THE SAFETY SCALPEL 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.