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

Model Number M1-5-1410

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2020

Event Type  malfunction  

Manufacturer Narrative

This report is a response to report # (b)(4) which was received by amt from the fda.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 has reached out to the customer in attempts to retrieve the device for examination and additional information regarding the report.We are awaiting return of the device for examination.Since the device has not been returned, a visual and functional evaluation could not be performed and device failure could not be confirmed at this time.A device history review could not be conducted as no lot number was provided.Based on the provided information, the reported problem is not believed to have been caused by a manufacturing defect.Complaint # (b)(4) was assigned to this report.We will provide additional information to the fda if the device or additional information is able to be obtained and an analysis changes the conclusion of this report.

Event Description

Per medwatch report #: (b)(4): "nurse heard a pop and went to check on infant.Found gastric tube out of patient lying in bed.When balloon was tested prior to reinsertion there was a hole in the balloon.".

• Brand Name: MINI ONE BALLOON BUTTON
• Type of Device: LOW PROFILE GASTROSTOMY BALLOON BUTTON
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine boulevard; brecksville, oh
• Manufacturer (Section G): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine boulevard; brecksville, oh
• Manufacturer Contact: joshua meinke ; 8006 katherine boulevard; brecksville, oh ; 7174000252
• MDR Report Key: 10080375
• MDR Text Key: 208364478
• Report Number: 1526012-2020-00006
• Device Sequence Number: 1
• Product Code: KNT
• 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: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M1-5-1410
• Device Catalogue Number: M1-5-1410
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2020
• Was Device Evaluated by Manufacturer?: No
• 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: 7 WK
• Patient Weight: 4