Description of Event or Problem · 0
ON (B)(6) 2025, THE INTERNAL BALLOON IN OUR DAUGHTER'S G TUBE (GASTROSTOMY TUBE) FAILED CAUSING IT TO BE DISLODGED. THIS REQUIRED US TO INSERT A FOLEY CATHETER AND TRAVEL TO THE EMERGENCY ROOM AT (B)(6) TO HAVE A NEW G TUBE INSERTED AND A FLUOROSCOPY TO CONFIRM PLACEMENT. IN THE TWO WEEKS SINCE SHE HAS HAD HER G TUBE, THIS IS THE SECOND TIME IT HAS FALLEN OUT DUE TO A MANUFACTURING DEFECT CAUSING THE INTERNAL BALLOON TO FAIL. THE FIRST TIME WAS ON (B)(6) 2025 WHILE SHE WAS STILL INPATIENT IN THE NEWBORN CRITICAL CARE CENTER. ON THAT TIME, SHE HAD TO WAIT 10 HOURS BETWEEN FEEDS DUE TO THE WAIT TO GET THE FLUOROSCOPY STUDY DONE TO CONFIRM PLACEMENT BEFORE SHE COULD BE FED AGAIN. AS A YOUNG INFANT, IT WAS VERY DISTRESSING FOR HER TO MISS MULTIPLE SCHEDULED FEEDS DUE TO THIS MANUFACTURING ERROR. WE WERE TOLD BY THE PEDIATRIC SURGERY TEAM AT (B)(6) THAT THEY CHECKED THE BALLOON AND THERE WAS A SMALL LEAK WHICH CAUSED IT TO FAIL. THEY SAID THEY HAVE CONTACTED THE MANUFACTURER IN THE PAST AND WERE TOLD THAT SOMETIMES THE LINING OF THE BALLOON IS SHAVED DOWN TOO FAR CAUSING IT TO FAIL PREMATURELY. THIS IS AN UNACCEPTABLE LEVEL OF MANUFACTURING ERROR WHICH HAS CAUSED DISTRESS AND DANGER TO OUR INFANT ON MULTIPLE OCCASIONS. THE PRODUCT IS CALLED A MINIONE BALLOON BUTTON LOW PROFILE GASTROSTOMY FEEDING TUBE. THE SIZE IS 12F X 1.0CM. IT IS MANUFACTURED BY APPLIED MEDICAL TECHNOLOGY; INC. WE ALSO HAD TO PAY A $(B)(6) EMERGENCY ROOM CO-PAY DUE TO THIS DEFECT.