INTERLINK

Additional Manufacturer Narrative

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.

Description of Event or Problem

IT WAS REPORTED THAT AN INTERLINK SYSTEM NON-DEHP MINIVOLUME EXTENSION SET LEAKED AFTER PRIMING. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

CORRECTION: THIS REPORT IS A DUPLICATE OF MANUFACTURER REPORT NUMBER 1416980-2024-05473. ALL INFORMATION CAN BE FOUND UNDER MANUFACTURER REPORT NUMBER 1416980-2024-05473. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

THIS REPORT IS A DUPLICATE COMPLAINT. ALL INFORMATION CAN BE FOUND IN THE REFERENCED MASTER COMPLAINT, (B)(4).