ARGYLE

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD (DHR) FOR LOT 2404400064 WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE OBSERVED. A VIDEO AND A FEW PICTURES WERE RECEIVED FOR EVALUATION AND THE REPORTED CONDITION WAS OBSERVED. A CORRECTIVE AND PREVENTIVE ACTION HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS ISSUE.

Additional Manufacturer Narrative

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

Description of Event or Problem

THE CUSTOMER REPORTED THAT THEIR NEONATAL ICU SITE HAS INCORRECT CONNECTORS FOR THE 3.5FR SINGLE LUMEN UMBILICAL VESSEL CATHETERS (UVC). THE HUB HAS TWO NOTCHES THAT DO NOT CONNECT WITH THEIR SYRINGES OR TUBING. WHILE TRYING TO CONNECT THE LINE, THE PRACTITIONERS KEPT TURNING THE CATHETER BUT WERE UNABLE TO GET IT TO CONNECT PROPERLY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER STATING THAT THEY ARE UNABLE TO FULLY SECURE A BD 5 ML SYRINGE ONTO THE UVC LUER ¿LUGS¿. THE ISSUE OCCURRED DURING 1ST ACCESS WITH THE SYRINGE. THE CUSTOMER VERIFIED MANUALLY AND NOTICED THAT THREADS WERE NOT ENGAGING WITH THE SYRINGE LUER. THE LUER LUGS APPEARED TO BE BENT AWAY FROM THE LUER, WHEN COMPARED WITH COMPONENT DESIGN. THE NURSES EVALUATED THE OTHER UVC PRODUCTS FROM THE SAME LOT AND CONNECTION WITH SYRINGE SEEMED TO FUNCTION AS INTENDED. THEY WERE ABLE TO SUCCESSFULLY CONNECT A SYRINGE OR OTHER DEVICE, WITHOUT AN ISSUE. A NURSE ALSO EVALUATED ATTACHING THE EXACT 5 ML SYRINGE USED IN THE REPORTED COMPLAINT TO ONE UVC LUER FROM THE SAME LOT (NOT THE SUBJECT OF COMPLAINT) AND SAID IT CONNECTED TO THE NEW UVC ACCEPTABLY AND NO ISSUE WAS OBSERVED. THERE WAS NO PATIENT HARM REPORTED.