KANGAROO

Additional Manufacturer Narrative

ONE DEVICE WAS RECEIVED FOR INVESTIGATION. A VISUAL TECHNICAL EVALUATION WAS PERFORMED AND THE REPORTED CONDITION WAS OBSERVED. 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 INSPECTION WAS PERFORMED TO REVIEW THE MANUFACTURING PROCESS. ALL PROCESSES WERE REVIEWED AND VERIFIED TO BE FUNCTIONING CORRECTLY. NO ABNORMAL CONDITIONS WERE FOUND THAT COULD CONTINUE TO TRIGGER THE REPORTED CONDITION. A DETAILED ANALYSIS OF THE FRACTURE AREA INDICATES THAT THE GEOMETRY OF THE CUT PRESENTS CHARACTERISTICS HIGHLY CONSISTENT WITH DAMAGE INDUCED BY A SHARP OBJECT, AS EVIDENCED BY THE CUT EDGE. IN ORDER TO DETERMINE A POSSIBLE RELATIONSHIP WITH THE MANUFACTURING PROCESS, REPLICATION TESTS WERE PERFORMED UNDER CONTROLLED CONDITIONS USING EQUIVALENT PRODUCT, WITHOUT BEING ABLE TO REPRODUCE THE SAME FAILURE MODE. BASED ON ALL AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. THE AVAILABLE TECHNICAL EVIDENCE DOES NOT SUPPORT A CAUSE RELATED TO THE MANUFACTURING PROCESS, AND THE CHARACTERISTICS OF THE DAMAGE SUGGEST A POSSIBLE EXTERNAL FACTOR OCCURRING AFTER PRODUCTION. THE COMPLAINT HAS BEEN COMMUNICATED TO RELEVANT PERSONNEL FOR AWARENESS PURPOSES. NO FURTHER CORRECTIVE OR PREVENTIVE ACTIONS ARE REQUIRED AS NO NONCONFORMITIES WERE IDENTIFIED IN THE PRODUCT OR THE PROCESS. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.

Additional Manufacturer Narrative

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

Description of Event or Problem

THE CUSTOMER REPORTED THE NURSE WENT TO ADJUST THE TAPE AND THE NG TUBE SNAPPED IN HALF. THE TUBE HAD TO BE REPLACED. PER ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2026, THE NG FEEDING TUBE WAS REMOVED BY HAND AND REPLACED WITH A NEW NG TUBE. NO SPECIAL PROCEDURE NEEDED TO BE PERFORMED.