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

Model Number 4-42XX

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Aspiration/Inhalation (1725); Hemorrhage/Bleeding (1888)

Event Date 09/10/2019

Event Type  Injury  

Manufacturer Narrative

This report is a response to user facility report # (b)(4).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.While the device is believed to have been placed properly in accordance with the instructions for use the excessive force used in the attempt to remove the gastric tube or bridle contributed to the patient's injury.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

The patient is a (b)(6) year old disabled individual but initially been admitted with respiratory failure had undergone intubation and placement of a nasogastric tube which was used for feeding secondary to failing a swallowing evaluation.The nasogastric tube was secured in place with a bridle wire.The patient had grabbed onto the gastric tube with the attempt to be avulsing it however secondary to the bridle wire not come through.Resulted in a nasal injury with extensive hemorrhage, the bleeding was profound to the point of causing aspiration.She was then quickly transferred to the emergency room where she was intubated and evacuated some tracheal clots and then went on to have her nose packed with rhino rocket's on either side.Pt.Required surgical intervention (b)(6) 2019.

• 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: 9286144
• MDR Text Key: 165297439
• Report Number: 1526012-2019-00008
• 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: health professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4-42XX
• Device Catalogue Number: 4-4214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: IRIS - NON APPLICABLE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 58