CARDINAL HEALTH

Description of Event or Problem

THE CUSTOMER REPORTED THE KENDALL ENTRIFLEX NASOGASTRIC FEEDING TUBE SIZE 10 FRENCH X 43 INCHES BECAME UN-INTACT WHILE INSERTED IN THE GASTRIC TRACT. THE TUBE APPEARED TO HAVE EXPANDED CAUSING IT TO RUPTURE AND BECOME DETACHED FROM THE PROXIMAL PORTION OF THE TUBE. PROXIMAL PORTION OF THE TUBE WAS REMOVED FROM THE PATIENT BUT APPROXIMATELY 30 CENTIMETERS OF THE DISTAL PORTION REMAINS INSIDE THE GASTRIC TRACT. PER ADDITIONAL INFORMATION PROVIDED ON 08-APR-2026, TO RESOLVE THE ISSUE, ANOTHER FEEDING TUBE WAS PLACED. THE FOREIGN BODY WAS NEVER REMOVED FROM THE PATIENT AS THEY PASSED AWAY FROM ACUITY OF ILLNESS, NOT RELATED TO THE FEEDING TUBE.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS NO LOT INFORMATION WAS PROVIDED WITHIN THE COMPLAINT. HOWEVER, PRIOR TO A LOT¿S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. DURING PRODUCTION, INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE AFFECTED PRODUCT COULD NOT BE EVALUATED TO CONFIRM THE REPORTED FAILURE MODE. A GEMBA ON-SITE INSPECTION OF THE MANUFACTURING PROCESS WAS CARRIED OUT. ALL PROCESSES WERE REVIEWED AND THEIR CORRECT OPERATION WAS VERIFIED. NO ABNORMAL CONDITIONS WERE FOUND THAT COULD CONTINUE TO TRIGGER THE REPORTED CONDITION. BASED ON ALL AVAILABLE INFORMATION AND GIVEN THAT NO SAMPLES OR IMAGES WERE AVAILABLE FOR TECHNICAL EVALUATION, A ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.