MAUDE Adverse Event Report: CORPAK MEDSYSTEMS, INC. CORFLO ULTRA NG FEEDING TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 20-7368

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/23/2019

Event Type  malfunction  

Event Description

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.

• Brand Name: CORFLO ULTRA NG FEEDING TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CORPAK MEDSYSTEMS, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8419801
• MDR Text Key: 138794975
• Report Number: 8419801
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/12/2019,01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 20-7368
• Device Catalogue Number: 20-7368
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/14/2019
• Type of Device Usage: N
• Patient Sequence Number: 1