MAUDE Adverse Event Report: COVIDIEN LLC COVIDIEN KANGAROO FEEDING TUBE

Catalog Number 8884-720825

Device Problem Retraction Problem (1536)

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

Event Date 01/19/2015

Event Type  malfunction  

Event Description

Unable to pull guide wire from dobhoff tube after it was inserted, had to remove the tube and insert a different one.

• Brand Name: COVIDIEN KANGAROO FEEDING TUBE
• Type of Device: COVIDIEN KANGAROO FEEDING TUBE
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire st; mansfield MA 02048
• MDR Report Key: 4540471
• MDR Text Key: 5513285
• Report Number: MW5040816
• Device Sequence Number: 1
• Product Code: FPD
• 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: 01/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8884-720825
• Device Lot Number: 415581064X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR