MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. AMT BRIDLE PRO; NASAL TUBE RETAINING SYSTEM

Model Number 4-42XX

Device Problems Inadequate or Insufficient Training (1643); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2019

Event Type  malfunction  

Manufacturer Narrative

This report is a response to user facility report # (b)(4).At the time of the report the device was still in use and had not been removed from the patient.Based on the provided information the reported incident was not caused by a manufacturing defect.The device functioned as intended and there was no malfunction as defined by the fda.Per the bridle directions for use once the bridle has been placed the excess tubing and magnet is intended to be cut and disposed of.Based on the provided information this was not done prior to the mri scan being initiated.The bridle device is mr safe when placed according to the instructions for use, which the user did not properly follow.We have assigned complaint # (b)(4) to this report and will provide additional information to the fda if the device or additional information is able to be obtained and its analysis changes the conclusion of this report.

Event Description

While moving the patient into the scan room, the rad tech assistant noticed that the end of the patient's feeding tube moved as they got closer to the magnet.The patient was removed from the scan room and it was discovered that there was a small, black, piece of metal on the tip of the feeding tube (on the end that was hanging out of the patient's nose).Prior to entering the scan room, the patient had been wanded and this tip did not alarm.The mri technologist reviewed the patient's chart and found that the patient had an amt bridle nasal tube.Per the manufacturer's website, the apparatus was "mr safe".Because metal is never considered "mr safe" more research was conducted.It was discovered that the metal tip was a magnet that should have been removed after the nasal tube was placed.The clinical administrator was called to mri.Clinical administrator stated that the magnet should have been clipped off and he did this himself with a pair of scissors.

• Brand Name: AMT BRIDLE PRO
• Type of Device: NASAL TUBE RETAINING SYSTEM
• 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: sarah beercheck ; 8006 katherine blvd.; brecksville, OH 44141 ; 4402622541
• MDR Report Key: 9226704
• MDR Text Key: 210633163
• Report Number: 1526012-2019-00007
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142971
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 4-42XX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2019
• 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 Outcome(s): Required Intervention