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

Model Number M1-5-XXXX

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

This report is a response to uf report # (b)(4) which was received by amt from the fda on 01/11/2021.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 has reached out to the customer via multiple attempts to retrieve additional information and the device for examination.No additional information was available regarding this report and no direct confirmation has been received whether the device is available for return.Since the device has not been returned, a visual and functional evaluation could not be performed and device failure could not be confirmed.A device history review could not be performed due to the lack of reported lot information.Based on the provided information the reported complaint is not believed to have been caused by a manufacturing defect.Complaint # (b)(4) was assigned to this report.We will continue to try and work with the original reporter to obtain the device in question and additional information if available.

Event Description

Per the initial report received in medwatch report #: (b)(4): "describe the event or problem: "patient is a baby with otc (ornithine transcarbamylase) deficiency.Patient got gt (gastrostomy tube) shortly after birth and pulled gt out last month.Gt was replaced by surgery.Amt button gt now has cracked where extension is to be connected, which makes it difficult to keep extension locked into tube because it no longer can lock d/t break.Rns checking feed often to ensure leak isn't happening, but some leaking was noted overnight.Rns taped extension down to prevent extension from dislodging from button.Mds aware, surgery consulted, awaiting to see if surgery can replace tube at bedside or if patient will have to wait till or next week to have it replaced.".

• Brand Name: AMT 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: 11302349
• MDR Text Key: 232379327
• Report Number: 1526012-2021-00002
• 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: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M1-5-XXXX
• Device Catalogue Number: M1-5-XXXX
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 2 MO