Y-TYPE TUR/BLADDER IRRIGATION SET

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, H3, H4, H6(UPDATE CODES), H11. H4: THE LOT WAS MANUFACTURED IN OCT 2024. H11: THE DEVICE AND A RETAINED SAMPLE WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED ON THE RETURNED SAMPLE WHICH REVEALED A DISCONNECTION OF THE SPIKE; HOWEVER, VISUAL INSPECTION OF THE RETENTION SAMPLE DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THE RETENTION SAMPLE WAS AIR/LEAK TESTED AND NO LEAK WAS OBSERVED AND THE SAMPLE WAS CONFORMING AS PER PRODUCT SPECIFICATIONS. THE REPORTED CONDITION WAS VERIFIED; HOWEVER, THE REPORTED CONDITION WAS NOT VERIFIED ON THE RETAINED SAMPLE. THE CAUSE OF THE ISSUE WAS DUE TO OPERATOR ERRORS RELATED TO ASSEMBLY ISSUE DURING MANUFACTURING. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

(B)(6). H11: SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A Y-TYPE TUR/BLADDER IRRIGATION SET DISCONNECTED DURING A 0.9% SODIUM CHLORIDE PRIMING WHICH RESULTED IN A LEAK. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.