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

Model Number	M1-5-1410-I
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is a response to uf report # (b)(4) which was received by amt from the fda on 01/31/2022.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.There were also no direct or indirect patient consequences reported due to the failure of the device.Amt worked with the customer to get the product back for examination and reviewed the device and production records for the reported batch.A large tear was noted through the tubing and over molded section of the device, just under the external bolster.Examination concluded that the tear was most likely caused during the placement process of the device by the end user.The tear was clearly caused by a sharp/abrasive object, possibly due to a suture or other device used during placement.Amt 100% inspects all product for proper tube and anti-reflux valve leakage prior to shipment, and production records indicate that product passed inspection/testing.There are no steps in between a final qc inspection and packaging that would have led to such a tear in the tube.A device history review was completed for the reported lot number and no anomalies were found and there have been no other complaint reports for this same batch (and no similar tears have been found from other batches).The complaint information has been logged into our complaint database for trending purposes.Complaint # (b)(4) was assigned to this report.
Event or Problem Description
Per the original reporter in uf report #: (b)(4): "g-tube was placed and found to be leaking around the base when feeds were administered for the first time.G-tube had to be replaced.Upon visual examination, there was what appears to be a fracture in the rubber near the base of the tube.It is unlikely the fracture occurred during placement and seems to be a manufacturing defect.In the photos, a piece of electronic solder was placed through the crack to make it more visible.Without the wire, the crack was extremely difficult to see.The balloon portion is intact and functions properly.".

• Brand Name: MINII 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: joshua meinke ; 8006 katherine boulevard; brecksville, OH 44141 ; 4407174000
• MDR Report Key: 13637474
• Report Number: 1526012-2022-00003
• Device Sequence Number: 2134672
• Product Code: KNT
• UDI-Device Identifier: 00842071113940
• UDI-Public: (01)00842071113940(17)240101(10)210212-013
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161413
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/01/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2024
• Device Model Number: M1-5-1410-I
• Device Catalogue Number: M1-5-1410-I
• Device Lot Number: 210212-013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2020
• 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: 2 YR
• Patient Sex: Male