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

Catalog Number M1-5-1220

Device Problems Material Rupture (1546); Split (2537)

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

Event Date 11/10/2016

Event Type  malfunction  

Manufacturer Narrative

This report is a response to uf report # (b)(4).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.Analysis of the returned devices consisted of a visual and functional evaluation, as well as a device history review.The examination determined that the reported incident is not believed to have resulted from a manufacturing defect.We have assigned complaint number (b)(4) to this report.(b)(4).

Event Description

This patient has had two amt g-tube balloons break prematurely (less than 30 days after tube inserted).G-tube site was tender to touch.On assessment a large gap between g-tube and belly was detected.There was no water in the g-tube balloon.Tube was removed from site with mild resistance.Balloon was deflated.Water was inserted into this g-tube; water immediately expelled from balloon due to a tear in the balloon.A g-tube should last at least 30 days.

• Brand Name: MINI ONE BALLOON BUTTON
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine blvd; brecksville OH 44141
• Manufacturer (Section G): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine blvd; brecksville OH 44141
• Manufacturer Contact: michelle scott ; 8006 katherine blvd; brecksville, OH 44141 ; 4407174000
• MDR Report Key: 6313968
• MDR Text Key: 67271062
• Report Number: 1526012-2017-00001
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K945618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 12/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/12/2019
• Device Catalogue Number: M1-5-1220
• Device Lot Number: 160512-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2016
• Date Manufacturer Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2016
• 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