FDA Adverse Event Malfunction Summary report: N

MINI ONE® BALLOON BUTTON

MDR report key: 22505978 · Received July 15, 2025

Report

Report Number
22505978
Event Type
Malfunction
Date Received
July 15, 2025
Date of Event
June 29, 2025
Report Date
July 9, 2025
Manufacturer
APPLIED MEDICAL TECHNOLOGY, INC.
Product Code
KNT
Product Problem
Yes
Report Source
User Facility report
Reporter Location
UT
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

CALLED TO BEDSIDE BY RN BECAUSE SHE NOTED INCREASED SPACE BETWEEN SKIN AND BASE OF G-TUBE, AND EASE OF MOVEMENT WITH DRESSING CARES. CALLED SURGICAL APP [ADVANCED PRACTICE PROVIDER] ON CALL. SHE RECOMMENDED OBTAINING DYE STUDY AND MAKING INFANT NPO IF ANY CONCERNS WITH G-TUBE, SAID SHE WOULD COME UP BUT ALSO THAT SHE WAS MANAGING TRAUMA AND WOULD LIKELY SEE IN AM. WE OBTAINED DYE STUDY, NORMAL WITHIN TRACT. BEDSIDE RN, CHARGE RN, MD AND MYSELF (APP) CHECKED IF THERE WAS ANY FLUID WITHIN G-TUBE BALLOON, MET RESISTANCE AND WERE UNABLE TO PULL ANYTHING OFF BALLOON. CHECKED OR [OPERATING ROOM] REPORT, INITIALLY HAD 4CC OF WATER IN BALLOON. RE-INSTILLED 0.5CC OF WATER BEFORE MEETING RESISTANCE. VERY LIKELY BASED ON EXAM THAT BALLOON HAD BEEN RUPTURED AND THIS IS WHY THERE WAS INCREASED MOVEMENT IN G-TUBE, DESPITE MAINTAINED WITHIN TRACT. I CALLED SURGICAL APP AND MADE AWARE OF FINDINGS REGARDING BALLOON, NORMAL DYE STUDY AND MAKING INFANT NPO [NIL PER OS]. SHE SAID THEY WOULD SEE INFANT IN AM. G-TUBE REPLACED FINALLY ON [DATE REDACTED] AND SURGICAL TEAM NOTED G-TUBE BALLOON HAD BEEN RUPTURED. PER PREVIOUS PATIENTS, THIS IS ONE OF MULTIPLE RECENT G-TUBES WITH ISSUES REGARDING BALLOON INTEGRITY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1770623 MINI ONE® BALLOON BUTTON TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT APPLIED MEDICAL TECHNOLOGY, INC. M1-5-1410-I 250326-205

Patients

Seq Age Sex Outcome Treatment
1 2 MO Male