ARGYLE

Additional Manufacturer Narrative

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

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE LUR-LOCK END OF UMBILICAL ARTERIAL CATHETER (UAC) WOULD NOT SCREW TIGHT TO TRANSDUCER END (SPINNING IN CONTINUOUS CIRCLE WITHOUT LOCKING). THE CUSTOMER TRIED ANOTHER TRANSDUCER AND SAME PROBLEM OCCURRED. THE CUSTOMER FURTHER STATED THAT THEY ATTACHED ANESTHESIA EXTENSION TUBING TO UAC ON ONE END AND THE OTHER TO TRANSDUCER. THERE WAS NO HARM REPORTED.

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD (DHR) FOR LOT 2430300084 WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE OBSERVED. THERE WERE NO PHOTOS OR PHYSICAL SAMPLES RECEIVED FOR EVALUATION. BECAUSE A SAMPLE WAS NOT RETURNED, WE WERE UNABLE TO PERFORM A FOLLOW UP INVESTIGATION TO INCLUDE FUNCTIONAL AND VISUAL EVALUATIONS TO CONFIRM THE ISSUE AND ROOT CAUSE ANALYSIS. HOWEVER, BASED ON THE PREVIOUS EVENTS REPORTED, A CORRECTIVE AND PREVENTATIVE ACTION HAS BEEN OPENED TO ADDRESS THE REPORTED ISSUE. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.