LACERATION KIT

Additional Manufacturer Narrative

INCIDENT TWO: THE PRODUCT INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION. MEDICAL ACTION INDUSTRIES IS THE MANUFACTURER OF THE CONVENIENCE KIT CONTAINING THE COMPLAINT COMPONENT, (B)(4), LOTS 2513R0598 AND 2504R0598, PURCHASED FROM SPECIFICATION DEVELOPER, GLOBAL INSTRUMENTS INC. (FDA REGISTRATION 1057200). 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.

Description of Event or Problem

THE CUSTOMER REPORTED THE HEMOSTAT BREAKING WHILE IN USE. THERE WERE NO PATIENT INJURY AND NO MEDICAL INTERVENTION REQUIRED. THE CUSTOMER CONFIRMED THE INSTRUMENT WAS CLAMPED ON THE CATHETER WHEN IT BROKE WHILE REMOVING THE CATHETER DURING ROUTINE PROCEDURE (NOT EMERGENCY PROCEDURE). THERE WAS DELAY OF APPROXIMATELY A FEW MINUTES FOR EACH PROCEDURE INVOLVED DURING CATHETER REMOVAL.

Additional Manufacturer Narrative

BASED ON THE DEVICE HISTORY RECORD THERE WERE NO NONCONFORMANCES DURING PRODUCTION OF THE COMPLAINT LOT. INSPECTION AND RELEASE PROCESSES WERE FOLLOWED. BASED ON THOSE PROCESSES, THE FINISHED GOOD WAS DETERMINED TO BE CONFORMING AT THE TIME OF COMMERCIAL DISTRIBUTION. A 12 MONTH REVIEW SHOWED NO SIGNIFICANT TRENDS FOR THIS ISSUE OR INVOLVING THIS KIT OR THIS INSTRUMENT. SUPPLIER (B)(4) ROOT CAUSE ANALYSIS IDENTIFIED THE FOLLOWING ROOT CAUSE(S): TOOL WEAR AND ALIGNMENT VARIATIONS DURING MANUFACTURING WHEREBY FINAL INSPECTION FAILED TO DETECT ISSUES. GLOBAL INSTRUMENTS INC. IMPLEMENTED THE FOLLOWING CORRECTIVE ACTIONS: REWORK OR REJECTION OF NON-CONFORMING INSTRUMENTS, TOOLING INSPECTION AND RECALIBRATION, ENHANCED FUNCTIONAL INSPECTION OF JAW ALIGNMENT, LOCKING, AND GRIPPING FORCE, IMPROVED CLEANING AND SURFACE VERIFICATION PRIOR TO FINAL INSPECTION, REINFORCEMENT OF INSPECTION CRITERIA WITH QA AND PRODUCTION STAFF. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21 CFR 803, 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.