INTERLINK

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED THAT THE RUBBER HUB AT THE Y-CONNECTOR OF AN INTERLINK NON-DEHP MINIVOLUME EXTENSION SET WAS DISPLACED WHICH RESULTED IN A FLUID LEAK. THIS ISSUE WAS OBSERVED WHILE PRIMING THE SET PRIOR TO PATIENT CONNECTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

CORRECTION: A1, D4: UNIQUE IDENTIFIER (UDI) #, D5. ADDITIONAL INFORMATION: D9, H3, H4, H6(UPDATE CODES), H11. H11: THE DEVICE WAS RECEIVED WITHOUT ITS PRIMARY PACKAGING FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED SAMPLE IDENTIFIED THE INCORRECT POSITION OF THE RUBBER (YELLOW RUBBER) AT THE COMPONENT Y-SITE. PRESSURE TEST WAS PERFORMED ON THE RETURNED SAMPLE, AND A LEAK WAS OBSERVED AT THE SAME LOCATION (Y-SITE) DUE TO THE INCORRECT POSITION OF THE RUBBER. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE WAS RELATED TO SUPPLIER MANUFACTURING PROCESS. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.