MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. MINI ONE(R) BALLOON BUTTON; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number M1-5-1410-I

Device Problems Device Dislodged or Dislocated (2923); Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2021

Event Type  malfunction  

Manufacturer Narrative

This report is a response to uf report # (b)(4), which was received by amt from the fda on 12/07/2021.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 confirmed that the device referenced in the report is not available for return.Since the device was not returned, a visual and functional evaluation could not be performed and device failure cannot be confirmed at this time.A device history review was completed for the reported lot number and no anomalies were found and there have been no other complaint reports from this same batch.The complaint information has been logged into our complaint database for trending purposes.Complaint # (b)(4) was assigned to this report.

Event Description

Based on the original reporter's provided report # (b)(4), "the internal retention balloon of the 14fr x 1.0cm minione® balloon button low profile feeding device leaked causing the gastrostomy tube to be dislodged from the patient.Patient's mother reported this as the second time this has happened, a similar situation occurred two weeks prior where the tube came out and the balloon was not intact.When trying to inflate the tube there was obvious leakage noted (lot 210715-116, expiration date 2024-06-01, ref # m1-5-1410-i).".

• Brand Name: MINI ONE(R) BALLOON BUTTON
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• 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: joshua meinke ; 8006 katherine boulevard; brecksville, OH 44141 ; 4407174000
• MDR Report Key: 13232815
• MDR Text Key: 285854684
• Report Number: 1526012-2021-00021
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00842071113940
• UDI-Public: (01)00842071113940(17)240601(10)210715-116
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: M1-5-1410-I
• Device Catalogue Number: M1-5-1410-I
• Device Lot Number: 210715-116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 5 MO
• Patient Sex: Male