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

Model Number 884711006

Patient Problem Insufficient Information (4580)

Event Date 08/28/2023

Event Type  malfunction  

Event Description

Placed the weighted 8 french tube feed.X ray and confirmed placement for tube feedings.Nurse went to remove the guidewire it would not come out, it was stuck - unable to remove ng tube /hardware.Removed tube guidewire intact.Nursing staff attempted to insert a regular ng tube and met residence.

• Brand Name: COVIDIEN KANGAROO NASOGASTRIC FEEDING TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 17710370
• MDR Text Key: 322945818
• Report Number: 17710370
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 884711006
• Device Catalogue Number: 8884711006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/31/2023
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25550 DA
• Patient Sex: Male