12FR 55 IRIS FEEDING TUBE ENF

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD (DHR) AND BUILD HISTORY WAS REVIEWED. THE DEVICE WENT THROUGH THE MANUFACTURING PROCESS WITHOUT FAILURE AND THE DEVICE PASSED INSPECTION WITHOUT ANY ABNORMALITIES. THE SUPPLIER REVIEWED ALL TEST LOGS OF THIS DEVICE AND IT PASSED ALL STATIONS WITHOUT ANY ABNORMALITIES. PHOTOS WERE PROVIDED FOR INVESTIGATION. THE SUPPLIER REVIEWED THE PHOTOS; THE EXTRUDED BOLUS TUBE OUTSIDE OF THE CAMERA PCBA AND THE GLASS CAP OF CAMERA WERE FOUND DETACHED FROM THE MAIN TUBE. FROM THE PHOTO, UV GLUE RESIDUE COULD BE OBSERVED. IT WAS DETERMINED THAT FOREIGN FORCE WAS ENCOUNTERED TO CAUSE THIS KIND OF CONDITION. THE END USER¿S HANDLING OF THE DEVICE IS SUGGESTED TO BE EVALUATED. IN ADDITIONAL, THE SUPPLIER REVIEWED THEIR PROCESS FLOW. THEY REVIEWED THE PARAMETER SETTING OF THE GLUE STATIONS ON THE DATE OF MANUFACTURE AND FOUND THAT THE PARAMETER WERE WITHIN SPECIFICATION. THE IN-PROCESS TENSILE TEST AND THE DESTRUCTIVE TEST FOR THE REPORTED BATCH WAS REVIEWED; ALL RESULTS PASSED. IT MUST BE NOTED THAT ALL TUBES ARE 100% INSPECTED BEFORE PACKAGING. BASED ON ALL AVAILABLE INFORMATION, THERE IS NO RISK IN THE MANUFACTURING PROCESS THAT WOULD CAUSE THE TUBE DETACHED ISSUE REPORTED THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED AND NO ACTION WILL BE TAKEN AT THIS TIME. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

Description of Event or Problem

THE CUSTOMER REPORTED FULL DEGRADATION OF MATERIAL AT THE DISTAL TIP OF THE IRIS FEEDING TUBE, IN BETWEEN EYELETS AND CAMERA, EXPOSING WIRING CONNECTED TO THE CAMERA WHILE INDWELLING IN PATIENT. THE PRODUCT WAS VISIBLY NOTICED UPON REMOVAL OF THE FEEDING TUBE FROM THE PATIENT. THE IRIS FEEDING TUBE WAS INITIALLY INSERTED ON (B)(6) 2021 AND REMOVED ON (B)(6) 2021, INDWELLING FOR 14 DAYS. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2021 STATED THAT THERE WAS VISIBLE COILING OF THE FEEDING TUBE IN THE STOMACH PER X-RAY IMAGING. THIS PROMPTED A RE-CONNECTION OF THE IRIS FEEDING TUBE TO THE CONSOLE IN ATTEMPT TO RE-PLACE IN THE EXPECTED LOCATION OF THE SMALL BOWEL. THE FEEDING TUBE WAS RECONNECTED TO THE IRIS CONSOLE WHILE STILL INDWELLING. THE CONSOLE IMAGING WAS NOT CLEAR, OTHER THAN WHAT APPEARED TO BE ORANGE COLORED BILE ENCOMPASSING THE IRIS CONSOLE SCREEN. THE FEEDING TUBE WAS RETRACTED IN AN ATTEMPT TO UNCOIL AND SUBSEQUENTLY TOTALLY REMOVED FROM PATIENT. SLIGHT RESISTANCE WAS MET WHEN PULLING THE DISTAL END OF THE IRIS TUBE OUT OF THE NARE UPON REMOVAL. AT THE POINT OF REMOVAL IS WHEN THE REPORTED ISSUE WAS CLEARLY VISIBLE. NO KNOWN INJURY OR MEDICAL INTERVENTION TO THE PATIENT BESIDES REMOVAL AND RE-PLACEMENT OF ANOTHER IRIS FEEDING TUBE.