CARDINAL HEALTH

Additional Manufacturer Narrative

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

Description of Event or Problem

THE CUSTOMER REPORTED AN ISSUE WITH THE NASOGASTRIC TUBES. SEVERAL NURSES HAVE REPORTED A PROBLEM WHEN REMOVING THE GUIDE WIRE AFTER THE TUBE HAS BEEN INSERTED. THEY STATED THAT THEY PROPERLY MOISTENED THE TUBE BEFOREHAND. THE REPORTER STATED THEY TESTED A TUBE THEMSELF, AND THE GUIDE SLIDES CORRECTLY AFTER HUMIDIFICATION. PER ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2026, THE ISSUE THE NURSES WERE EXPERIENCING WAS THAT THEY WERE COMPLETELY UNABLE TO REMOVE THE STYLET. IT WAS STATED THAT THEY PUT WATER IN THE TUBE BUT THE PROCESS USED AND QUANTITY OF WATER INJECTED IS NOT KNOWN. TO RESOLVE THE ISSUES, THE FEEDING TUBE HAS BEEN REMOVED AND REPLACED. NO FURTHER INFORMATION IS AVAILABLE REGARDING SPECIFIC INCIDENTS.

Additional Manufacturer Narrative

A DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE AFFECTED PRODUCT COULD NOT BE EVALUATED TO CONFIRM THE REPORTED FAILURE MODE. THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. 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 LOT MET ALL DEFINED CRITERIA AND WAS RELEASED. A GEMBA WALK WAS HELD IN THE PRODUCTION AREA. AS A RESULT, IT WAS CONCLUDED THAT THE CURRENT MANUFACTURING ACTIVITIES ARE RUNNING ACCORDING TO PRODUCT SPECIFICATIONS MEETING QUALITY ACCEPTANCE CRITERIA, VALIDATION PROCESS AND RELEASED PROCEDURES. NO ABNORMAL CONDITIONS WERE FOUND THAT COULD TRIGGER THE REPORTED CONDITION. BASED ON ALL AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.