WOUND KIT

Additional Manufacturer Narrative

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 2518R0643G AND 2534R0634P PURCHASED FROM SPECIFICATION DEVELOPER, GLOBAL INSTRUMENTS INC. (FDA REGISTRATION 1057200). <BR /> THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). <BR /> 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

ON (B)(6) 2026, THE CUSTOMER REPORTED A HEMOSTAT BROKE AFTER CHEST TUBE WAS REMOVED. THE HEMOSTAT WAS BEING USED TO CLAMP CHEST TUBE FOR REMOVAL. NO PATIENT INJURY, TREATMENT, OR DELAYS OCCURRED. THE BREAK HAPPENED AFTER BEDSIDE CHEST TUBE REMOVAL, NOT DURING AN EMERGENCY PROCEDURE.

Additional Manufacturer Narrative

CUSTOMER'S PHOTO AND SAMPLE CONFIRMED THE REPORTED FAILURE. THERE IS NO INVENTORY OF THE COMPLAINT KIT OR THE INSTRUMENT LOTS INVOLVED. THE DEVICE HISTORY RECORD WAS REVIEWED WITH NO NONCONFORMANCES DURING PRODUCTION OF THE COMPLAINT LOT. NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS KIT OR LOT NUMBER. SUPPLIER, GLOBAL INSTRUMENTS, INC. DETERMINED ROOT CAUSE: TOOL WEAR AND ALIGNMENT VARIATION DURING MANUFACTURING. INSUFFICIENT FINAL FUNCTIONAL INSPECTION EFFECTIVENESS. ASSEMBLY ALIGNMENT VARIATION. CORRECTIVE ACTIONS IMPLEMENTED: TOOLING INSPECTION AND RECALIBRATION. ENHANCED FUNCTIONAL INSPECTIONS FOR JAW ALIGNMENT, LOCKING AND GRIPPING FORCE. REINFORCEMENT OF INSPECTION CRITERIA WITH BOTH QUALITY ASSURANCE AND PRODUCTION STAFF. GLOBAL INSTRUMENTS INC. ACKNOWLEDGE THE SERIOUSNESS OF THE REPORTED CONCERNS AND CONFIRM THIS ISSUE HAS BEEN HANDLED WITH TOP PRIORITY. 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.