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

Catalog Number 4-4110

Device Problems Entrapment of Device (1212); Mechanical Problem (1384); Device Issue (2379); Positioning Problem (3009)

Patient Problems Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)

Event Date 03/14/2016

Event Type  Injury  

Manufacturer Narrative

This report is in response to the medwatch voluntary report entered by the user facility.Based on the reported information, there was no death nor did this result in permanent impairment or a serious injury that is life-threatening, as defined by the fda.However, due to the improper placement of the device, intervention was required to remove the magnet from the patient's nasal cavity.A device history review was completed and no anomalies were observed.We contacted the user facility in an attempt to retrieve the device, but they declined to return the device at this time, so the device could not be evaluated and device failure could not be confirmed.We 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.We have assigned (b)(4) to this report.

Event Description

Patient's dobhuff feeding tube was replaced per process.A decision was made to bridle the feeding tube to secure it in place, which was unsuccessful.Upon the removal of the magnetic stem from the patient's nose, the magnet from the white stem detached from the device and lodged in the bridge of the patient's nose.Attempts to manually retrieve the white magnetic stem were unsuccessful.An x-ray and ct scan revealed the magnet to be in the patient's nasal cavity superiorly along the right aspect of the nasal septum.An ent was consulted, who took the patient to surgery to successfully remove the magnet.

• Brand Name: AMT BRIDLE
• 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: michelle scott ; 8006 katherine blvd; brecksville, OH 44141 ; 4407174000
• MDR Report Key: 5597053
• MDR Text Key: 43301172
• Report Number: 1526012-2016-00005
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 4-4110
• Device Lot Number: 15084086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2016
• Initial Date FDA Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2015
• 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
• Patient Age: 68 YR