TUR IRRIGATION SET

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H4, H6 (UPDATE CODES), H11. H4: THE SUSPECT LOT 24G23T363 WAS MANUFACTURED JULY 2024 AND SUSPECT LOT 24J31T423 WAS MANUFACTURED OCTOBER 2024. H11:THE DEVICE WAS DISCARDED; HOWEVER, RETAINED SAMPLES FROM THE SUSPECT LOTS WERE EVALUATED. THE RETAINED SAMPLES WERE VISUALLY INSPECTED AND NO OBVIOUS ISSUE/DAMAGE WERE DETECTED; THE SAMPLES WERE CONFORMING PER PRODUCT SPECIFICATIONS. THE RETAINED SAMPLES WERE AIR/LEAK TESTED AND NO LEAKS WERE OBSERVED. THE REPORTED CONDITION WAS NOT VERIFIED ON THE RETAINED SAMPLES. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THESE SUSPECT LOTS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

D4 LOT #: THE SUSPECT LOT WAS EITHER FROM 24G23T363 OR 24J31T423. E1: INITIAL REPORTER ADDRESS: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE LUER CONNECTOR OF A UROMATIC TUR ADMINISTRATION SET SEPARATED AND LEAKED AROUND 5ML OF NORMAL SALINE. THIS WAS OBSERVED DURING PATIENT TRANSPORTATION AFTER SURGERY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.