CARDINAL HEALTH

Description of Event or Problem

THE CUSTOMER REPORTED A DOBHOFF WAS PLACED FOR A CRITICAL PATIENT IN ICU. THE DOBHOFF BECAME OCCLUDED, WHICH DOES OCCUR FROM TIME TO TIME. STAFF DID THE PROTOCOL TO UNCLOG THE TUBE WITH THE ENZYME (PANCRELIPPASE 12,000U IN A 0.4% SODIUM BICARB). THIS ENZYME IS PART OF THE TUBE FEEDING ORDER SET. THIS ENZYME UNCLOGGED THE DOBHOFF FOR AROUND 2 HOURS. 2 HOURS LATER THE TUBE WAS CLOGGED AGAIN SO STAFF DECIDED TO PULL THE TUBE AND TO REPLACE WITH A NEW ONE PER PHYSICIAN ORDER. IT WAS AN EASY PULL OUT, HOWEVER WHEN THEY PULLED THE TUBE, THEY NOTICED THE END OF THE TUBE WAS MISSING. UPON X-RAY, IT WAS OBSERVED THAT THE END OF THE DOBHOFF REMAINED IN THE STOMACH. THIS PATIENT THEN HAD TO HAVE A PROCEDURE TO REMOVE THE END THAT WAS REMAINING IN THE STOMACH. PER ADDITIONAL INFORMATION PROVIDED ON JUNE 09, 2026, THE FEEDING TUBE WAS IN PLACE FOR 12 HOURS BEFORE THE OCCLUSION ALARM OCCURRED. THERE WERE ALARMS FOR DISLODGED TUBE THROUGHOUT HALF OF THE MORNING. THE PLACEMENT WAS ROUTINE, THE STYLET REMOVAL WAS UNEVENTFUL, AND PLACEMENT WAS CONFIRMED VIA X-RAY. THE TUBE WAS NOT REPOSITIONED AFTER PLACEMENT NOR WAS THE STYLET EVER REINSERTED. OTHER THAN THE ENZYME USED, COKE AND WARM WATER WERE ALSO USED AS AN UNCLOGGING METHOD. THE PATIENT WAS INTERMITTENTLY CONFUSED AND DID PULL ON THE TUBE BUT A BRIDLE WAS IN PLACE. ANOTHER FEEDING TUBE WAS PLACED PRIOR TO THE REMOVAL OF THE AFFECTED TUBE. THERE WAS NO RESISTANCE DURING REMOVAL. THE PORTION OF THE TUBE THAT REMAINED IN THE PATIENT'S STOMACH WAS REMOVED VIA ESOPHAGOGASTRODUODENOSCOPY.

Additional Manufacturer Narrative

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