ARGYLE

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE CATHETER WAS INSERTED ON (B)(6) 2025 IN THE MORNING AT THE OBSTETRIC CENTER, AND ON (B)(6) 2025 AT NIGHT IT WAS OBSERVED THAT IT LEAKED WHEN INJECTED INTO THE PRIMARY LUMEN. THE NEWBORN WAS IN A MINIMUM HANDLING PROTOCOL, REQUIRING MANIPULATION. DURING THE INVESTIGATION, IT WAS VERIFIED THAT THERE WAS A LEAK IN THE CATHETER EXTENSION WHEN ONE OF THE ROUTES WAS USED. DUE TO THE LEAK, TWO (02) DAYS AFTER INSERTION, THE CATHETER WAS REMOVED AND A PICC WAS NECESSARY. PER CUSTOMER, THE UMBILICAL CATHETER USUALLY REMAINS IN PLACE FOR UP TO SEVEN (07) DAYS FOR PLANNING ANOTHER VENOUS ACCESS; THERE WAS NO PATIENT HARM REPORTED.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD (DHR) FOR LOT 2320700127 WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE OBSERVED. THERE WERE NO SAMPLES RETURNED FOR EVALUATION; HOWEVER, A VIDEO WAS PROVIDED FOR ANALYSIS. UPON INSPECTION, THE CATHETER SHOWED SIGNS OF USE, AND THE CATHETER HAD A LEAK IN THE TUBE. BASED ON THE INFORMATION PROVIDED, IT WAS DETERMINED THAT THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE IS THAT THE CATHETER WAS DAMAGED DURING USE. THE INSTRUCTIONS FOR USE OUTLINE THE CORRECT WAY TO USE THE CATHETER AND HOW TO AVOID THE TYPE OF DAMAGE OBSERVED ON THE DEVICE. PER INSTRUCTION OF USE, CATHETER SHOULD NOT BE PINCHED OR BENT BACK TO TEMPORARILY OCCLUDE THE CATHETER, SINCE IT INCREASES STRESS ON THE CATHETER OR PIGTAIL WHICH CAN LEAD TO A LEAK OR BREAK. BASED ON THIS INFORMATION, NO CORRECTIVE ACTIONS ARE WARRANTED AT THIS TIME. THIS INFORMATION WILL BE USED FOR TRACKING AND TRENDING PURPOSES, AND WE WILL CONTINUE TO MONITOR.