CARDINAL HEALTH

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE DOBHOFF TIP NG TUBE BROKE INTO TWO PIECES WHILE INDWELLING IN THE PATIENT. A PORTION OF THE FEEDING TUBE WAS RETAINED WITHIN THE PATIENT. THE BREAK OF THE TUBE OCCURRED AT THE AREA OF 5.6-8CM ON THE TUBE. THE TUBE WAS INDWELLING FOR 2 DAYS BEFORE BREAK. THE REMAINING PORTION OF TUBE WAS REMOVED ENDOSCOPICALLY. FEED HISTORY: JEVITY 1.5 CAL. WATER HISTORY: 11/13 30 ML Q4H: 1522, 1742, 2059, 11/14 50 ML Q4H: 0128, 0550, 0930, 1302, 1706, 2108, 11/15 100 ML Q4H: 0130, 0520, 0913, 1316, 1811, 2200. MEDICATION HISTORY: AMIODARONE, ASPIRIN, LIPITOR, LISINOPRIL, LOPRESSOR, MULTIVITAMIN, OXYCODONE, GYLCOLAX, SENAKOT-S, BRILINTA, TRAZADONE, POTASSIUM CHLORIDE. SUPPLEMENT HISTORY: PROSOURCE 60 ML TID, BANATROL 60 ML BID.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

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 DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE AFFECTED PRODUCT COULD NOT BE EVALUATED TO CONFIRM THE REPORTED FAILURE MODE. AS PART OF THE INVESTIGATION, A GEMBA WALK WAS HELD IN THE PRODUCTION AREA AND IT WAS CONCLUDED THAT THE CURRENT MANUFACTURING ACTIVITIES ARE RUNNING ACCORDING TO PRODUCT SPECIFICATIONS MEETING QUALITY ACCEPTANCE CRITERIA, VALIDATION PROCESS, AND RELEASED PROCEDURES. ALL PROCESSES AND CONTROLS WERE FOUND TO BE FOLLOWED CORRECTLY, INCLUDING PACKAGING AND ALL INSPECTIONS CARRIED OUT ON THE PRODUCT. NO 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.