FDA Adverse Event Injury Summary report: N

MINIONE BALLOON BUTTON LOW PROFILE GASTROSTOMY FEEDING TUBE

MDR report key: 24145353 · Received January 22, 2026

Report

Report Number
MW5182622
Event Type
Injury
Date Received
January 22, 2026
Report Date
January 16, 2026
Manufacturer
APPLIED MEDICAL TECHNOLOGY INC.
Product Code
KNT
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
SC, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND
Health Professional
*

Narratives

Description of Event or Problem · 0

MY 2.5YO SON'S GTUBE BUTTON (MINIONE REF M1-1215-I FROM APPLIED MEDICAL TECHNOLOGY INC.) HAS BROKEN AND CEASED WORKING ON FOUR OCCASIONS IN THE PAST TWO WEEKS DESPITE NORMAL USE. WE HAVE DEPLETED OUR SUPPLIES REPLACING THESE BUTTONS, WHICH ARE LASTING ABOUT 72 HOURS ON AVERAGE BEFORE BREAKING. THE SAME PATTERN REPEATS: THE INNER RING CRACKS AND THEN PREVENTS THE EXTENSION CONNECTOR FROM LOCKING INTO PLACE SO WE CANNOT DELIVER EITHER HIS FOOD OR MEDICATIONS. MY SON REQUIRES 24HR GTUBE ACCESS TO PREVENT HYPERAMMONEMIA, WHICH MAY CAUSE PERMANENT NEUROLOGICAL DAMAGE, COMA, AND DEATH. THERE IS NO COMMON LOT NUMBER, MANUFACTURING DATE, OR SUPPLIER SOURCE ACROSS ALL FOUR BROKEN BUTTONS, AND OTHER FAMILIES HAVE REPORTED IN MEDICAL FACEBOOK GROUPS THE SAME FAILURE IN OTHER PARTS OF THE COUNTRY, SUGGESTING THERE MIGHT BE A WIDESPREAD MANUFACTURING DEFECT. I HAVE CONTACTED AMT TO REPORT THE ISSUE AND REQUEST REPLACEMENT SUPPLIES, WHICH THEY INDICATED THEY WILL DO AT THE END OF A 2-4 WEEK INVESTIGATION AND TO UTILIZE THE ED FOR RESUPPLY IN THE INTERIM. PT CODE: 4582. DEVICE CODES: 1069, 2292. REFERENCE: MW5182620, MW5182621, MW5182623.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
214117 MINIONE BALLOON BUTTON LOW PROFILE GASTROSTOMY FEEDING TUBE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT APPLIED MEDICAL TECHNOLOGY INC. M1-1215-I 250922-318

Patients

Seq Age Sex Outcome Treatment
1 24 MO Male Required Intervention| L CITRULLINE.| G-TUBE (WHEN IT'S WORKING).| RAVICTI, MEDICINAL FORMULA.