SAFETY SCALPEL, 22 BLADE LIGHT/SKY BLUE NS

Description of Event or Problem

WE HAVE RECEIVED A RATHER SERIOUS CUSTOMER COMPLAINT WHERE AN END-USER HAS CUT THEMSELVES ON A CONTAMINATED NO22 RETRACTABLE SCALPEL. THE SCALPEL HAS BEEN USED AND THEN THE BLADE HAS BEEN RETRACTED INTO THE PASSING POSITION. DUE TO THE TIGHTNESS OF THE TRIGGER, THE TIP OF THE BLADE HAS NOT BEEN FULLY RETRACTED IN THE SCALPEL AND THEY HAVE CUT THEMSELVES.

Additional Manufacturer Narrative

A USER FACILITY COMPLAINT WAS RECEIVED ON 11/25/2022, REPORTING, "WE HAVE RECEIVED A RATHER SERIOUS CUSTOMER COMPLAINT WHERE AN END-USER HAS CUT THEMSELVES ON A CONTAMINATED NO22 RETRACTABLE SCALPEL. THE SCALPEL HAS BEEN USED AND THEN THE BLADE HAS BEEN RETRACTED INTO THE PASSING POSITION. DUE TO THE TIGHTNESS OF THE TRIGGER, THE TIP OF THE BLADE HAS NOT BEEN FULLY RETRACTED IN THE SCALPEL AND THEY HAVE CUT THEMSELVES." NO ADDITIONAL INFORMATION REPORTED. PATIENT STATUS IS UNKNOWN. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE SAFETY SCALPEL SUPPLIER (B)(4). THE SAMPLE IS NOT AVAILABLE FOR RETURN TO DEROYAL FOR EVALUATION. 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 AND CORRECTIVE ACTIONS ARE DETERMINED.

Additional Manufacturer Narrative

A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE SAFETY SCALPEL SUPPLIER (B)(4). THE SAMPLE IS NOT AVAILABLE FOR RETURN TO DEROYAL FOR EVALUATION. ROOT CAUSE: WAS DETERMINED TO BE UNKNOWN. THE DEVICE WAS NOT RETURNED FOR ANALYSIS AND WAS OVER 5 YEARS OLD. IT WAS NOTED THAT THIS WAS ONLY COMPLAINT OF THE (B)(4) PIECES PRODUCED IN THIS LOT. A (B)(4) PIECE SAMPLE SIZE WAS MADE FOR TESTING AND NO DEFECTS WERE FOUND. NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN BY (B)(6), BUT THEY WILL CONTINUE TO MONITOR FOR TRENDS. DEROYAL CONDUCTED A REVIEW OF THE WORK ORDERS AND FAILURE MODES AND EFFECT ANALYSIS (FMEA) WAS IT FOUND TO HAVE NO DISCREPANCIES. AN INVENTORY CHECK WAS PERFORMED BY DEROYAL WITH (B)(4) SAFETY SCALPELS WERE INSPECTED WITH NO DISCREPANCIES FOUND. DEROYAL HAS SOLD (B)(4) CASES OF FINISHED GOOD ITEM (B)(6) FROM (B)(6) 2020 TO PRESENT AND DURING THIS REVIEW PERIOD A TOTAL OF (B)(4) COMPLAINT HAS BEEN RECEIVED FOR THIS ITEM. THIS EQUATES TO A SALES RATIO OF (B)(4). DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS RELATED TO THIS COMPLAINT. ADDITIONAL INFORMATION WAS RECEIVED DECEMBER 5 AND INTERNALLY APPROVED ON DEC 12. THIS FOLLOW UP MDR IS BEING SUBMITTED AFTER THE 30 DAY MARK DUE TO AN INTERNAL ADMINISTRATIVE ERROR. 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.