ARGYLE

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. THE DEVICE WAS RECEIVED FOR EVALUATION AND VISUAL INSPECTION SHOWED SIGNS OF USE. UPON EVALUATION, KINKED CATHETER WAS OBSERVED AND 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 CATHETER KINK OBSERVED ON THE RETURNED DEVICE. THIS INFORMATION WILL BE USED FOR TRACKING AND TRENDING PURPOSES, AND WE WILL CONTINUE TO MONITOR.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE LINE WAS POSSIBLY FAULTY. UPON CARE SET, THE MOTHER STATED THAT SHE FELT SOMETHING ¿WET¿ WHILE HOLDING. THE LINE WAS ASSESSED AND A ¿PINPRICK" HOLE WAS NOTED NEAR BIFURCATION OF UVC. THERE WAS NO HARM REPORTED.

Additional Manufacturer Narrative

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