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 THE UAC NOTICED TO BE SHORT UPON REMOVAL. AN X-RAY CONFIRMED THE UAC RETENTION. A NEW 3.5FR UAC CATHETER IDENTICAL TO THE ONE USED ON THE PATIENT WAS TESTED. IT WAS STRETCHED WITH SIGNIFICANT FORCE TO ASSESS FRAGILITY. THE CATHETER DID NOT BREAK. THE ASSESSMENT IS THAT THE UAC DISSECTED UPON REMOVAL AS IT WAS COMPROMISED OR DEFECTIVE IN SOME WAY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE BABY HAD AN UMBILICAL EXPLORATION WHICH FAILED AND A BESIDE EXPLORATORY LAPAROSTOMY WAS PERFORMED WHERE THE CATHETER WAS FOUND AND REMOVED.

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD (DHR) FOR LOT 2318100195 WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE OBSERVED. THE DEVICE WAS RECEIVED FOR EVALUATION AND VISUAL INSPECTION SHOWED SIGNS OF USE, AND CATHETER BROKE WAS OBSERVED. 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 BREAKAGE OBSERVED ON THE RETURNED DEVICE. THIS INFORMATION WILL BE USED FOR TRACKING AND TRENDING PURPOSES, AND WE WILL CONTINUE TO MONITOR.

Additional Manufacturer Narrative

SECTION H 10 (ADDITIONAL MANUFACTURER NARRATIVE): ORIGINALLY REPORTED AS "THE DEVICE HISTORY RECORD (DHR) FOR LOT 2318100195 WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE OBSERVED" AND SHOULD BE "THE DEVICE HISTORY RECORD (DHR) FOR LOT 2403100242 WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE OBSERVED".