FDA Adverse Event Malfunction Summary report: N

CORFLO ULTRA NG FEEDING TUBE

MDR report key: 8419801 · Received March 14, 2019

Report

Report Number
8419801
Event Type
Malfunction
Date Received
March 14, 2019
Date of Event
January 23, 2019
Report Date
January 24, 2019
Manufacturer
CORPAK MEDSYSTEMS, INC.
Product Code
KNT
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CT
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

PATIENT NEEDED NGT PLACED. UPON FIRST ATTEMPT RN FELT TUBING KINK IN BACK OF THE THROAT, TUBE REMOVED AND DISCARDED. SECOND ATTEMPT PLACED BUT NO GASTRIC ASPIRATE NOTED, CXR OBTAINED AND TUBING NOTED TO BE KINKED IN STOMACH. RESIDENT INFORMED NURSE TO REPLACE. WHEN THIS TUBE WAS REMOVED IT WAS NOTED TO BE KINKED AT DISTAL END OF TUBING. THIRD NGT PACKAGE OPENED AND NGT INSPECTED BEFORE PLACED, IT WAS NOTED THAT THIS TUBE WAS ALREADY KINKED BEFORE EVEN BEING PLACED. TUBE SAVED FOR INSPECTION AND NOT USED. FOURTH NGT PACKAGE OPENED, TUBING INSPECTED AND NO KINKS. TUBE PLACED AND GASTRIC ASPIRATE OBTAINED. TUBE NOTED TO BE BADLY KINKED AT NARE, TUBE HAD TO BE RE-TAPED AND TAPED DOWN FACE TOWARDS JAW INSTEAD OF STRAIGHT ACROSS FACE TO EAR TO AVOID TUBE BEING KINKED. ANOTHER NURSE NOTED THAT A PATIENT ON THE FLOOR WHO HAD AN NGT PLACED LAST NIGHT ALSO HAS THE TUBING KINKED AT THE NARE. THIS IS UNUSUAL FOR TUBING TO BE KINKED SO EASILY LIKE THIS. THE SET OF TUBING NOTED TO BE KINKED BEFORE USING ON PATIENT WAS SAVED AND ALSO THE PACKAGE OF THAT TUBING AND OF THE TUBING CURRENTLY IN USE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
215116 CORFLO ULTRA NG FEEDING TUBE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CORPAK MEDSYSTEMS, INC. 20-7368

Patients

Seq Age Sex Outcome Treatment
1