MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. BALLOON G-TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	7-1410
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Per the original reporter in fda report #: (b)(4), "amt's balloon g-tube will not securely hold tubing for feeding in either port.When tubing connected to either port, it quickly slides out.Tubing is needing to be "taped" in place while feeding is going so that patient receives his feeding.Health care provider checked in with nurse, mom and patient today.The problem seems to be at the connection point between the enteral end of the g-tube and the christmas-tree-like connector of the tubing.There is a crack, which is preventing a tight seal.Clinical staff are using tape and a posey to create a seal for the next three weeks, when the g-tube will be healed enough to be able to change it out.Surgery and neonatology are aware of this plan and approve.Health care provider have placed a note at the bedside to save this tube for our products department for evaluation following removal.".
Additional Manufacturer Narrative
This report is a response to report # (b)(4) which was received by amt from the fda on 10/31/2022.Based on the provided information, the incident 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 reached out to the reporter in attempts to retrieve the device for examination.The reporter has confirmed that the device is available for examination and is working on returning the device for amt inspection.Since the device was not returned at the time of this report, a visual and functional evaluation could not be performed and device failure could not be confirmed.A device history review found no defects and no similar complaints have been reported from the same manufactured batch, and similar complaints have not been reported.Based on the provided information the reported problem is not believed to have been caused by a manufacturing defect.It is uncertain whether the leakage is being caused by the amt device, or the adapter that is being used to connect to the device.The g-tube device has two ports for connecting to, so it is extremely unlikely that both ports would be damaged and lead to leakage, which points to the non-amt adapter being the likely cause for leakage.Complaint # (b)(4) was assigned to this report.We will provide additional information to the fda if additional information is able to be obtained and its analysis changes the conclusion of this report.

• Brand Name: BALLOON G-TUBE
• Common Device Name: 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: 15844706
• Report Number: 1526012-2022-00018
• Device Sequence Number: 20328883
• Product Code: KNT
• UDI-Device Identifier: 00842071116408
• UDI-Public: (01)00842071116408(17)250101(10)220412-285
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K971434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/12/2022

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
• Device Expiration Date: 01/01/2025
• Device Model Number: 7-1410
• Device Catalogue Number: 7-1410
• Device Lot Number: 220412-285
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 3 MO
• Patient Sex: Male
• Patient Weight: 3 KG