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 ON (B)(6)2024, WHEN TRYING TO DISLODGE THE UMBILICAL TIE ON THE BABY CORD STUMP, THE UMBILICAL CATHETER BROKE, AND A FINGER LENGTH LEFT INSIDE THE BABY WITH THE TIP SEEN ON THE STUMP. PER CUSTOMER, THE DOCTOR RIGHT AWAY PULLED IT OUT USING THE TWEEZER.

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD (DHR) FOR LOT 2311100143 WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE OBSERVED. A PICTURE WAS RECEIVED FOR EVALUATION AND VISUAL INSPECTION SHOWED SIGNS OF USE SUCH AS RESIDUES OF BLOOD, AND A BREAKAGE IN THE TUBE WAS OBSERVED, CAUSING THE LEAK. 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 BREAK OBSERVED ON THE PICTURE. THIS INFORMATION WILL BE USED FOR TRACKING AND TRENDING PURPOSES, AND WE WILL CONTINUE TO MONITOR.