FDA Adverse Event Injury Summary report: N

MINI ONE BALLOON BUTTON

MDR report key: 21795943 · Received April 8, 2025

Report

Report Number
21795943
Event Type
Injury
Date Received
April 8, 2025
Date of Event
March 13, 2025
Report Date
April 1, 2025
Manufacturer
APPLIED MEDICAL TECHNOLOGY, INC.
Product Code
KNT
Adverse Event
Yes
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

PATIENT HAD A NEW GT [GASTRIC TUBE] PLACED ON [REDACTED]. FOR THE FIRST NIGHT SHIFT CARES AT 2000, MOM AND BEDSIDE REGISTERED NURSE (RN) WERE DOING GT CARES. WE REMOVED THE BLUE TAPE AND CAREFULLY CLEANED INSERTION SITE; INFANT COUGHED AND BORE DOWN AND GT JUST POPPED RIGHT OUT. THE BALLOON WAS NOT INFLATED. RN PLACE GT BACK IN AND CALLED NP [NURSE PRACTITIONER] WHO CALLED THE SURGICAL TEAM. THE SURGICAL TEAM CAME TO BEDSIDE AND CHECKED THE BALLOON, AND THE FLUID TO INFLATE THE BALLOON APPEARED TO JUST GO INTO TUBE AND DID NOT INFLATE THE BALLOON. IT WAS DETERMINED AT THAT TIME THAT THE BALLOON WAS POPPED OR HAD A HOLE. SURGEONS THEN REPLACED THE GT WITH A NEW ONE AND INFLATED THAT BALLOON. DEVICE WAS TAPED TO PATIENT AND PLACEMENT WAS CHECKED VIA CONTRAST KUB [KIDNEY, URETER, AND BLADDER X-RAY] IN THE IR [INTERVENTIONAL RADIOLOGY]. IMAGES CONFIRMED NEW TUBE WAS IN PROPERLY PLACED AND AFTER TALKING WITH THE BEDSIDE NP, WE WERE TOLD TO GO AHEAD WITH USUAL OPERATIONS OF MEDICATION AND VENTING. MANUFACTURER RESPONSE FOR TUBES, GASTROINTESTINAL (AND ACCESSORIES), MINI ONE® BALLOON BUTTON (PER SITE REPORTER). APPLIED MEDICAL TECHNOLOGY PROVIDED A RETURN LABEL FOR THE SAMPLE SAVED FROM THIS EVENT. WE HAVE NOT RECEIVED ANY INVESTIGATION RESULTS AS OF [REDACTED].

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
459382 MINI ONE BALLOON BUTTON TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT APPLIED MEDICAL TECHNOLOGY, INC. M1-5-1210-I

Patients

Seq Age Sex Outcome Treatment
1 5 MO Female Hospitalization