MAUDE Adverse Event Report: MOOG MEDICAL DEVICES GROUP 500ML ENTERAL FEEDING BAG WITH ENFIT CONNECTOR; ENTERAL FEEDING SETS

Model Number INF0500-A

Device Problems Fluid/Blood Leak (1250); Split (2537); Connection Problem (2900)

Patient Problem Unspecified Infection (1930)

Event Date 05/24/2015

Event Type  malfunction  

Event Description

Customer stated: "purple connection came in split, split begins at the flange outside the connection tip mid body to the part, the edge of the tip is intact.Causing the fluid to stream out.1 set.Patient had spinal fusion surgery [recently].The formula wet the bed for a course of 4 hours causing his bandages to get wet and caregiver noticed it 30 hours later when realized the bandage had been compromised causing an infection, patient was taken to the emergency room and was seen for 5 hours with a diagnosis of celoitis bacterial skin infection that entered through his surgery incision and sent home with antibiotics and antifungal cream for treatment.".

Manufacturer Narrative

The device in question is new to the market.It is are 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.Moog 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 being phased out by early 2016.Since the introduction of the new enfit connector-containing enteral feeding sets earlier this year, moog 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.The event described in this report is one of the few moog has received that alleges a patient having experienced an injury due to the administration sets leaking.The complainant did not return the affected sets for evaluation.However, moog is in the process of conducting extensive testing on un-released samples and samples received back from other complaints.The investigation is still ongoing.Preliminary results point to the leaking being related to components which have been supplied to moog by a single supplier -- (b)(4) based manufacturer of disposable biomedical devices and components.Further investigation is still required, however, to reach a final conclusion.Moog will report the results of the investigation as they become available.Device not returned to the manufacturer.

• Brand Name: 500ML ENTERAL FEEDING BAG WITH ENFIT CONNECTOR
• Type of Device: ENTERAL FEEDING SETS
• Manufacturer (Section D): MOOG MEDICAL DEVICES GROUP; 4314 zevex park lane; salt lake city UT 84123
• Manufacturer (Section G): MOOG MEDICAL DEVICES GROUP; 4314 zevex park lane; salt lake city UT 84123
• Manufacturer Contact: matt brinkerhoff ; 4314 zevex park lane; salt lake city, UT 84123 ; 8012641001
• MDR Report Key: 4851369
• MDR Text Key: 5931920
• Report Number: 1722139-2015-00008
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 05/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Home Health Aide
• Device Model Number: INF0500-A
• Device Catalogue Number: INF0500-A
• Device Lot Number: CF1503704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ELLECARE JR
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR
• Patient Weight: 83