CLEARLINK

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO D9, H3, H4, AND H6. H11: ONE ACTUAL DEVICE AND PHOTOGRAPHS OF THE SAMPLE WERE RECEIVED FOR EVALUATION. THE RETURNED PHOTOGRAPHS WERE REVIEWED, AND IT WAS NOTED THAT THERE WAS BLOOD FLOW ON THE SET. THE ACTUAL DEVICE WAS VISUALLY INSPECTED, AND ALL COMPONENTS WERE CORRECTLY PLACED AND ACCORDING TO THE SPECIFICATION. THE SAMPLE WAS THEN SUBMITTED TO PRESSURE TESTING AND NO LEAK WAS NOTED. IN ADDITION, THE SAMPLE WAS SUBMITTED TO CLEAR PASSAGE TEST AND NO ISSUES WERE OBSERVED. THE REPORTED CONDITION WAS NOT VERIFIED FOR THE ACTUAL SAMPLE THAT WAS EVALUATED; HOWEVER, WAS VERIFIED IN THE PHOTOGRAPH SAMPLE. THE CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED. 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.

Additional Manufacturer Narrative

D4 LOT #: THE IMPACTED PRODUCT POTENTIALLY HAD ONE OF THESE TWO LOT #S: DR25F26062, DR25F16017 D4 UDI #: SUSPECT LOT DR25F26062 HAS A UDI # (B)(4) SUSPECT LOT DR25F16017 HAS A UDI # (B)(4) E1 INITIAL REPORTER PHONE NUMBER: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A Y-TYPE BLOOD/SOLUTION SET WITH STANDARD BLOOD FILTER LEAKED FROM A PORT DURING INFUSION. THE TUBING WAS IMMEDIATELY DISCONTINUED AND REPLACED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.