NA

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, H3, H6 (UPDATE CODES), H11. H11: THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION OF THE ACTUAL SAMPLE DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. A PRESSURE TESTING WAS PERFORMED ON THE SAMPLE; A LEAK WAS OBSERVED IN THE AIR VENT OF THE FILTER. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION IS RELATED TO THE MANUFACTURING PROCESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

D4: LOT #: THE SUSPECTED LOT NUMBERS ARE DR24L06079, DR25D22031 AND 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 OCCURRED AFTER PRIMING. 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.