INTERLINK

Additional Manufacturer Narrative

B3/D10: THE EVENT OCCURRED DURING AN UNSPECIFIED DATE OF DECEMBER 2025. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE CHAMBER (BLOOD FILTER) OF AN INTERLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET LEAKED. THE ISSUE WAS NOTICED WHILE ADMINISTERING PRBC (PACKED RED BLOOD CELLS). THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D4 EXPIRATION DATE (UPDATE 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 DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.