NA

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO A1, A2, A3A, A4-A6, B5, B6, B7, D10, H6 (UPDATE CODES) AND H11. A2, A3A, A4-A6, B6, B7, D10: UPDATE THE NULL VALUE TO N/A. B5: IT WAS FURTHER CONFIRMED THAT THAT NO LEAKAGE OCCURRED; HOWEVER, THE ISSUE WAS BEING UNABLE TO FLUSH DURING PRIMING, PRIOR TO PATIENT CONNECTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. H11: UPON RECEIPT OF ADDITIONAL INFORMATION, IN THE EVENT THESE DEVICES ARE UNABLE TO BE PRIMED, THE CLINICIAN CAN CHOOSE TO REPLACE THE DEVICE BY RETRIEVING A NEW ONE, OR IN THE EVENT OF AN EMERGENCY CONNECT A SYRINGE OR ADMINISTRATION SET DIRECTLY TO THE CATHETER. THEREFORE THERE IS NO POTENTIAL FOR HARM TO THE PATIENT IN THE EVENT OF INABILITY TO PRIME. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

CORRECTION TO D4 (LOT AND UDI): UPDATE. ADDITIONAL INFORMATION: D4: EXPIRATION DATE (UPDATE THE NULL VALUE TO N/A), H4, H6 (UPDATE CODES), H11. H11: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICES WERE DISCARDED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT AN UNSPECIFIED AMOUNT OF MICRO-VOLUME EXTENSION SETS LEAKED FROM AN UNSPECIFIED LOCATION. THIS WAS OBSERVED DURING SETUP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.