MAUDE Adverse Event Report: COVIDIEN COVIDIEN KANGAROO NASOGASTRIC FEEDING TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Lot Number 180680311

Device Problems Difficult to Insert (1316); Failure to Advance (2524)

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

Event Date 07/18/2018

Event Type  Injury  

Event Description

Dobbhoff stylet feeding tube inserted into lung.First attempt unable to insert into esophagus, + yellow at 30 cm so not advanced.Second attempt with + yellow at 30 cm.Last attempt at 30 cm, co2 detector remained purple and tube advanced to 68 cm.Cxr confirmed lung placement.

• Brand Name: COVIDIEN KANGAROO NASOGASTRIC FEEDING TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 7725569
• MDR Text Key: 115358867
• Report Number: MW5078629
• Device Sequence Number: 0
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2019
• Device Lot Number: 180680311
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR