ARGYLE

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD (DHR) FOR LOT NUMBER 2332400065 WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE OBSERVED. THE DEVICE RETURNED BY THE CUSTOMER IS NOT MANUFACTURED BY THE CARDINAL HEALTH. THEREFORE, IT IS NOT POSSIBLE TO PERFORM FUNCTIONAL OR VISUAL TESTS, AND THE REPORTED ISSUE WAS NOT OBSERVED. BASED ON THIS INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, AND NO CORRECTIVE ACTIONS ARE WARRANTED AT THIS TIME.

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

Description of Event or Problem

THE CUSTOMER REPORTED A DEVICE FAILURE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE LINE WAS PULLED OUT 1 CM WITHOUT THE USE OF ANY TWEEZERS OR SCISSORS AND WITHOUT REPORTED TENSION. THE LINE IMMEDIATELY STARTED LEAKING AND EVENTUALLY WAS DISCOVERED TO BE DUE TO A SLIT IN THE CATHETER. THERE WAS AN IVF (INTRAVENOUS FLUID) AND BLOOD LOSS. PER CUSTOMER, BLOOD SUGAR WAS DROPPED HOWEVER, DID NOT REQUIRE A TREATMENT. NO ANEMIA OR HYPOVOLEMIA OBSERVED. THERE WAS A CONCERN FOR INTRODUCTION OF INFECTION AND CBC WAS CHECKED AND IT WAS WITHIN NORMAL LIMITS. THERE WAS NO PATIENT HARM REPORTED. THE DEVICE WAS REMOVED.