MAUDE Adverse Event Report: COVIDIEN ADAPTOR TRANSITION ENFIT; ENTERAL FEEDING TRANSITION CONNECTOR

Device Problems Inadequacy of Device Shape and/or Size (1583); Fitting Problem (2183); Connection Problem (2900)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

Enfit adapter connector for enteral feeding, does not fit all connections.It needs to fit to perform enteral feeding.The tip is shorter and wider than previous connectors.The first graduation shaft is shorter so connection is less secure (versus previous connector that had longer shaft).Due to this, it pops out during feedings making terrible mess and losing valuable breast milk or formula.Happens routinely and is not acceptable.This device was meant to bridge during the entire transition and is not proving compatible across all the needed connections.Connector is also wider so causes fit issues as well.Enfit connector used with feeding tubes, feeding extension sets, etc.Dates of use: (b)(6) 2015.

• Brand Name: ADAPTOR TRANSITION ENFIT
• Type of Device: ENTERAL FEEDING TRANSITION CONNECTOR
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 5045402
• MDR Text Key: 24787492
• Report Number: MW5055858
• Device Sequence Number: 1
• Product Code: PIF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Report Date: 08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Other Device ID Number: 765000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention