NA

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, H3, H6 AND H11. 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 AT 45 PSI AND NO LEAKS WERE NOTED. THE REPORTED CONDITION WAS NOT VERIFIED. 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.

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.