MAUDE Adverse Event Report: MOOG MEDICAL DEVICES GROUP BAG SET, 0500ML, WITH ENFIT CONNECTOR; ENTERAL FEEDING SET

Model Number INF0500-A

Device Problem Leak/Splash (1354)

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

Event Date 09/27/2016

Event Type  malfunction  

Manufacturer Narrative

The device in question is new to the market.It is one of the first enteral bag/administration sets to incorporate the new enfit connectors, which were specifically designed to be exclusively compatible with enteral feeding tubes.(b)(4) is one of the first companies to bring enfit connector-containing products to the market, but others will shortly follow suit.In fact, the enfit connectors are scheduled to become the industry standard over the course of 2015, with the older christmas-tree-style connectors scheduled to be phased out of the industry by early 2016.Since the introduction of the new enfit connector-containing enteral feeding sets earlier this year, (b)(4) has received a number of complaints about the new sets, the most common being that they leak in the vicinity of the purple enfit connector piece and the white transitional stepped connector.No injury to a patient was alleged in this particular complaint, and (b)(4) has not received any additional information indicating that a patient was or may have been harmed as a result of the reported event.(b)(4) would not normally submit an mdr for this event, but is doing so now because this particular issue (leaky enfit connector) has caused a reportable injury to a patient within the last two years.The complainant did not return the affected set(s) for evaluation.

Event Description

The initial reporter stated that the administration set was "leaking from the white connector." there was no adverse events or delay in therapy reported.(b)(4).

• Brand Name: BAG SET, 0500ML, WITH ENFIT CONNECTOR
• Type of Device: ENTERAL FEEDING SET
• Manufacturer (Section D): MOOG MEDICAL DEVICES GROUP; 4314 zevex park lane; salt lake city UT 84123
• Manufacturer (Section G): MOOG MEDICAL DEVICES GROUP, SRL; coyol free zone and; business park; alajuela, san jose 20113 ; CS 20113
• Manufacturer Contact: kristin hardesty ; 4314 zevex park lane; salt lake city, UT 84123 ; 8012641001
• MDR Report Key: 6058006
• MDR Text Key: 58413462
• Report Number: 1722139-2016-00587
• Device Sequence Number: 1
• Product Code: PIO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient Family Member or Friend
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Model Number: INF0500-A
• Device Catalogue Number: INF0500-A
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 1722139-11/19/15-001-C
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 27