MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. MINI ONE® BALLOON BUTTON; LOW PROFILE GASTROSTOMY FEEDING TUBE

Model Number	M1-5-1208-I
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Per the original reporter in uf #: (b)(4), it was reported that the, "g-tube was discovered to have dislodged.Upon investigation by medical personnel, the balloon was found to have a hole and had become deflated.This made it so that it slipped out by itself.The g-tube was still considered critical and patient had to have new g-tube placed by surgeon at the bedside.Patient was unable to get needed meds and food during the time that the g-tube wasn't working.It was discovered when meds and formula were found to have made swaddle blanket wet".
Additional Manufacturer Narrative
This report is a response to medsun report # (b)(4) which was received by amt from the fda on 11/10/2024.The occurrence was originally reported to amt on 07/08/2024 by the same initial reporter.It was originally reported that this device was in use for 15 days from 06/14/2024-06/29/2024 before balloon failure occurred, while the information marked in the medsun report stated the device was in use for 1 day.For reporting purposes, the device life of 15 days and occurrence date of 06/29/2024 were reported in this form.It was reported that the device was replaced, and that no patient injury occurred.It is noted there was a delay in feeds and medication, but this was promptly restored with the placement of a new device.Based on the provided information, the complaint is not a reportable event per 21 cfr section 803.There was no death.There was no serious injury, as defined by the fda.This was not life-threatening, nor did this result in permanent impairment or necessitate medical or surgical intervention to preclude permanent impairment.Amt worked with the original reporter to obtain the device for examination and performed an inspection of the device once returned.A tear in the balloon wall was identified on the returned device.Recent trending data shows no anomalies in reported failures from the field.The complaint information has been logged into our complaint database for trending purposes.Reporting information and device investigation can be found under complaint # (b)(4).

• Brand Name: MINI ONE® BALLOON BUTTON
• Common Device Name: LOW PROFILE GASTROSTOMY FEEDING TUBE
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine boulevard; brecksville OH 44141
• Manufacturer (Section G): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine boulevard; brecksville OH 44141
• Manufacturer Contact: ellyn smith ; 8006 katherine boulevard; brecksville, OH 44141 ; 4402622539
• MDR Report Key: 20631190
• Report Number: 1526012-2024-00011
• Device Sequence Number: 8038933
• Product Code: KNT
• UDI-Device Identifier: 00842071113810
• UDI-Public: 00842071113810
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K945618
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M1-5-1208-I
• Device Catalogue Number: M1-5-1208-I
• Device Lot Number: 230929-117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 5 MO
• Patient Sex: Female