LACERATION MCKESSON 20/CS

Description of Event or Problem

THE SCISSOR IN THIS KIT WAS FOUND TO BE RUSTY. ON 02/10/24, THE CUSTOMER REPORTED THE CLINIC HAD RUST FALL FROM BRAND NEW IRIS SCISSORS ON STERILE FIELD. THE CUSTOMER STATED THE SCISSORS WAS NOT USED WHEN ASKED IF DETECTED BEFORE USE. CUSTOMER CONFIRMED THE RUST FELL ON THE STERILE FIELD ONLY. NO RUST FELL INTO THE PATIENT'S WOUND/SURGICAL SITE. THE WAS A 15-MINUTE DELAY TO SET UP A NEW STERILE FIELD.

Additional Manufacturer Narrative

THE PRODUCT INVOLVED IN THIS EVENT IS NOT AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

Additional Manufacturer Narrative

PHOTO RECEIVED CONFIRMED THE FAILURE REPORTED. DEBRIS APPEARED TO BE RUST BETWEEN THE TWO SCISSOR BLADES AND AROUND THE RIVET THAT JOINS THE TWO SCISSOR BLADES. TWO SCISSOR SUPPLIERS AND LOTS WERE UTILIZED WITHIN THE MANUFACTURE OF THIS CONVENIENCE KIT. WITHOUT THE PHYSICAL SAMPLE TO VERIFY THE SUPPLIER'S MANUFACTURING STAMP ON THE SCISSOR, IT IS NOT POSSIBLE TO DETERMINE WHICH SUPPLIER IS RESPONSIBLE FOR THE COMPLAINT. THE DEVICE HISTORY RECORD WAS REVIEWED WITH NO NONCONFORMANCES REPORTED DURING PRODUCTION OF THIS COMPLAINT LOT. QA AUDITORS INSPECT THE INSTRUMENTS TO CONFIRM THE INSTRUMENT IS CORRECT AND CONFIRMS THERE IS NO DEBRIS OR OTHER ABNORMALITIES AS PART OF IN-PROCESS INSPECTIONS. FOR THIS COMPLAINT LOT, THREE QA INSPECTIONS PASSED. A TWELVE-MONTH REVIEW OF THE TRENDING DATABASE SHOWS NO ADDITIONAL COMPLAINTS RECEIVED FOR THIS INCIDENT. THIS INSTRUMENT AND SAME SCISSOR LOTS WERE PLACED IN A WIDE VARIETY OF SIMILAR CONVENIENCE KITS WITH NO ADDITIONAL COMPLAINTS RECEIVED FROM CUSTOMERS. BASED ON THE INVESTIGATION AND TRENDING ANALYSIS, WE CONCLUDED THIS ISSUE TO BE ISOLATED. SUPPLIER NOTIFICATION WAS SENT TO BOTH SUPPLIERS (GLOBAL INSTRUMENTS INC. AND TAMZON INSTRUMENTS, INC.) FOR HEIGHTENED AWARENESS OF THIS COMPLAINT. NO CORRECTIVE ACTIONS ARE TAKEN AT THIS TIME. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.