KIT: LACERATION 20/CS

Description of Event or Problem

THE ISSUE WAS DISCOVERED ON (B)(6) 2026, IN THE EMERGENCY ROOM WHILE A DOCTOR WAS STITCHING A CHILD'S HEAD WOUND. THIS WAS THE ONLY REPORTED CASE. AS SOON AS THE PROBLEM WAS IDENTIFIED, ALL INSTRUMENT TRAYS FROM THE SAME LOT WERE REMOVED FROM USE, AND NO OTHER PATIENTS WERE KNOWN TO BE AFFECTED. WHEN THE DOCTOR NOTICED THAT METAL WAS FLAKING FROM THE INSTRUMENT, THEY IMMEDIATELY STOPPED USING IT, THOROUGHLY CLEANED THE WOUND, AND SENT THE CHILD HOME WITH ANTIBIOTICS. IT IS BELIEVED THAT ALL OF THE METAL PIECES WERE REMOVED FROM THE WOUND. THERE WAS NO DELAY IN PROCEDURE. IN ADDITION, WHEN ANOTHER TRAY FROM THE SAME LOT WAS OPENED AND INSPECTED, SMALL METAL FLAKES WERE OBSERVED COMING OFF THE FORCEPS WHEN THEY WERE OPENED AND A FINGER WAS GENTLY RUBBED ACROSS THE SERRATED GRIPPING SURFACE.

Additional Manufacturer Narrative

A REPRESENTATIVE SAMPLE IS SAID TO BE AVAILABLE FOR EVALUATION BUT HAS NOT BEEN RECEIVED YET. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION. MEDICAL ACTION INDUSTRIES IS THE MANUFACTURER OF THE LACERATION KIT CONTAINING HEMOSTAT (CURVED) COMPONENT, R0632- (LOT 265R0632). THE LOT MANUFACTURED IN THE COMPLAINT CONVENIENCE KIT WAS SOURCED FROM SUPPLIER, GLOBAL INSTRUMENTS. (FDA REGISTRATION 9681540). THE SCAR WAS ISSUED TO THE SUPPLIER ON (B)(6) 2026. 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.