ARGYLE

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD (DHR) FOR LOT NUMBER 2411200089 WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE OBSERVED. THERE WERE NO SAMPLES RETURNED FOR EVALUATION; THEREFORE, THE AFFECTED DEVICE COULD NOT BE EVALUATED TO CONFIRM THE REPORTED ISSUE. AS SUCH, A ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. HOWEVER, 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. SECTION H10: ADDITIONAL MANUFACTURER NARRATIVE HAS BEEN UPDATED.

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD FOR 2411200089 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. AT THIS TIME, A CORRECTIVE AND PREVENTIVE ACTION IS NOT DEEMED NECESSARY. WE WILL KEEP MONITORING THE PROCESS FOR ANY ADVERSE TRENDS THAT REQUIRE IMMEDIATE ATTENTION. THIS COMPLAINT WILL BE USED FOR QA TRACKING AND TRENDING PURPOSES.

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 CATHETER WAS DEFECTIVE. PER CUSTOMER, THERE SEEMS TO BE A PROBLEM WITH THE LUER PORTION OF THE CATHETER. WHEN PLACING A NEGATIVE PRESSURE CAP ON THE END OF THE CATHETER, THE CAP CONTINUES TO SPIN AND NEVER "LOCKS" IN PLACE AND THEN IS EASILY PULLED OFF. THERE WAS NO PATIENT HARM REPORTED.