MAUDE Adverse Event Report: CORPAK MEDSYSTEMS CORFLO FEEDING TUBE; CORPAK FEEDING TUBE

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 09/26/2017

Event Type  malfunction  

Event Description

Corpak feeding tube had a leak in the tubing.

• Brand Name: CORFLO FEEDING TUBE
• Type of Device: CORPAK FEEDING TUBE
• Manufacturer (Section D): CORPAK MEDSYSTEMS
• MDR Report Key: 6975833
• MDR Text Key: 90395932
• Report Number: MW5072940
• Device Sequence Number: 1
• Product Code: FPD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/25/2017
• 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: 1
• Patient Age: 5 YR