NA

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, H3, H4, H6 (UPDATE CODES), H11. H4: THE SUSPECTED LOTS DR25D22031 AND DR24L06079 WAS MANUFACTURED ON 04/23/2025. H11: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THE SET UNDERWENT FUNCTIONAL PRESSURE TESTING, AND A LEAK WAS OBSERVED IN THE AIR VENT OF THE FILTER. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE WAS DUE TO A SUPPLIER 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

D4: LOT #: THE SUSPECTED LOT NUMBER IS EITHER DR24L06079, DR25D22031 OR DR25F17 (THIS LOT IS NOT VALID). D4: EXPIRATION DATE: THE EXPIRATION DATE FOR THE SUSPECTED LOT DR24L06079 IS 12/31/2029. THE EXPIRATION DATE FOR THE SUSPECTED LOT DR25D22031 IS 04/30/2030. D4: UNIQUE IDENTIFIER (UDI) #: THE UDI# OF THE SUSPECTED LOT DR24L06079 IS (B)(4). THE UDI# OF THE SUSPECTED LOT DR25D22031 IS (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A NON-DEHP MICRO-VOLUME EXTENSION SET LEAKED FROM THE AIR VENT. THE ISSUE WAS OBSERVED DURING PATIENT USE. THE DEVICE WAS ATTACHED TO A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC). THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.