MAUDE Adverse Event Report: ENFIT LUERLOCK ADAPTER; ENTERAL SPECIFIC TRANSITION CONNECTORS

Device Problems Connection Problem (2900); Output Problem (3005)

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

Event Type  No Answer Provided  

Event Description

I am writing to report the error potential with enfit-luerlock adapters.I believe these adapters have a high risk for error and tubing misconnections.Here are 2 examples of the available products.Https://www.Qosina.Com/enfit; https://www.Rxcrush.Com/products.(b)(6).

• Brand Name: ENFIT LUERLOCK ADAPTER
• Type of Device: ENTERAL SPECIFIC TRANSITION CONNECTORS
• MDR Report Key: 8879896
• MDR Text Key: 154912579
• Report Number: MW5088931
• Device Sequence Number: 1
• Product Code: PIO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1