CLEARLINK BLOOD RECIPIENT SET

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED THAT TWO (2) BLOOD/SOLUTION ANAESTHESIA/PCA INFUSION SETS WERE FAILING; THE "SIDE ARM" OF THE SET SPONTANEOUSLY CRACKED MIDWAY THROUGH THE CASE AND STARTED LEAKING ONTO THE FLOOR. THIS HAPPENED DURING CLINICAL USE WITH TOTAL INTRAVENOUS ANAESTHESIA (TIVA). THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

CORRECTION TO B5: IT WAS REPORTED THAT A BLOOD/SOLUTION ANAESTHESIA/PCA INFUSION SET WAS FAILING (PREVIOUSLY REPORTED AS A QUANTITY OF 2); THE "SIDE ARM" OF THE SET SPONTANEOUSLY CRACKED MIDWAY THROUGH THE CASE AND STARTED LEAKING ONTO THE FLOOR ADDITIONAL INFORMATION WAS ADDED TO H6. H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE AND RETENTION SAMPLES WERE PROVIDED FOR EVALUATION. THE RETURNED PHOTOGRAPH WAS REVIEWED, AND IT WAS NOTED THAT THERE WAS A CRACK AT THE LEVEL OF LUER. THE RETENTION SAMPLES WERE VISUALLY INSPECTION AND THERE WERE NO OBVIOUS ISSUE/DAMAGE NOTED. THE RETENTION SAMPLES WERE ALSO LEAK TESTED AND NO ISSUES WERE OBSERVED. THE REPORTED CONDITION WAS VERIFIED IN THE PHOTOGRAPHIC 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.