FDA Adverse Event Malfunction Summary report: N

AMT BRIDLE NASAL TUBE RETAINING SYSTEM

MDR report key: 3161378 · Received June 3, 2013

Report

Report Number
3161378
Event Type
Malfunction
Date Received
June 3, 2013
Date of Event
May 7, 2013
Report Date
June 2, 2013
Manufacturer
APPLIED MEDICAL TECHNOLOGY INC
Product Code
KNT
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MI, US

Narratives

Description of Event or Problem · 1

BRIDLE WAS IN PROCESS OF BEING PLACED WHEN PATIENT STARTED COUGHING. BOTH GUIDE ENDS OF MAGNET GUIDES HAD BEEN FULLY ADVANCED, BUT NO 'CLICK' HAD BEEN FELT PRIOR TO PATIENT'S COUGHING AND SPITTING FIT. AFTER PATIENT RELAXED, THE BLUE PORT WAS 3/4 OF THE WAY OUT OF PATIENT'S NOSE AND ORANGE END OF GUIDEWIRE WAS NOT NOTED. AFTER COMPLETELY REMOVING THE BLUE GUIDE AND INSPECTING PATIENT'S NARE, RN REALIZED THAT THE WIRE WAS STILL INSIDE OF PATIENT'S NOSE. WIRE WAS SECURED SO IT WOULD NOT FALL BACK INTO PATIENT'S THROAT. NG TUBE WAS REMOVED TO SEE IF WIRE WOULD COME FREE, MD WAS NOTIFIED AND ENT WAS PAGED FOR REMOVAL OF GUIDE WIRE WITH SCOPE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?TUBE FEEDING.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
243719 AMT BRIDLE NASAL TUBE RETAINING SYSTEM TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT APPLIED MEDICAL TECHNOLOGY INC N/A 13043266

Patients

Seq Age Sex Outcome Treatment
1 41 YR