MAUDE Adverse Event Report: MOOG MEDICAL DEVICES GROUP ENTERAL ADMINISTRATION SET WITH ENFIT, 500 ML; ENTERAL FEEDING SETS

Model Number INF0500-A

Device Problems Fluid/Blood Leak (1250); Material Integrity Problem (2978)

Patient Problems Hypoglycemia (1912); Lethargy (2560)

Event Date 09/29/2015

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.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), an italy-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.

Event Description

The initial reporter described an incident in which one of moog's enteral administration sets leaked, leading to her child not receiving an overnight feeding and becoming hypoglycemic.In the words of the mother: "we have a (b)(6) with a glucose disease, glycogen storage disease, he requires continuous nighttime feeding to keep his sugar stable.He cried out early yesterday morning while still hooked up to the pump.He was severely hypoglycemic (glucose below 20), lethargic, and on the verge of seizing.The tube got clamped when he rolled over in bed (we have no idea at what time that happened or for how long it had been like that) normally, the pump would alarm in that situation.Except we found a puddle of formula under him, the formula was leaking out of the enfit connector between the purple part and the 'christmas tree'." on a follow-up call to the mother, moog also learned that the mother self-treated the child by giving 23 gms of sugar water via the child's feeding tube, which raised the blood sugar from <20 to above 45 within 5 minutes and 145 in 1 hour.The pump had been set to feed overnight, rate 60 ml/hr, approximately 10 hours.The child eats food during the day and the mother provides supplemental tube feed boluses throughout the day.[(b)(4)].

• Brand Name: ENTERAL ADMINISTRATION SET WITH ENFIT, 500 ML
• 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: 5180302
• MDR Text Key: 30039475
• Report Number: 1722139-2015-00026
• Device Sequence Number: 1
• Product Code: PIF
• 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: other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: Yes
• 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: 09/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 2 YR