MAUDE Adverse Event Report: MOOG MEDICAL DEVICES GROUP 1200ML ENTERAL BAG SET WITH ENFIT CONNECTOR; ENTERAL FEEDING SETS

Model Number INF1200-A

Device Problem Fluid/Blood Leak (1250)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418); Underdose (2542)

Event Date 05/01/2015

Event Type  Injury  

Event Description

Moog received the following report of a product problem and product-related adverse event: administration sets provided by moog for use with its enteral pumps leaked, causing harm to the patient.The devices in question were being used by a pediatric patient diagnosed with mitochondrial disease.Over the course of an unspecified amount of time, several of moog's new enteral feeding sets with enfit connectors leaked at the point "where the purple port connect[s] to the white adapter." the leaks were extensive enough that the patient did not receive normal feedings, and had blood sugar drop to 40.The patient then experienced "possible seizure activity." during a follow-up call, the patient's mother described the reported seizure activity as the patient's "body was limp and [the patient] was unresponsive." the patient's mother administered (b)(6), after which the patient recovered to a normal state.There has been no other report of low blood sugar or seizure activity since the reported event.

Manufacturer Narrative

The device in question are new to the market.They are some 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 moog receives from a single supplier -- (b)(4)-based manufacturer of disposable biomedical devices and components.Further investigation is required, however, to reach a final conclusion.Moog will report the results of the investigation as they become available.Device not returned to manufacturer.

• Brand Name: 1200ML ENTERAL BAG SET 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: 4841315
• MDR Text Key: 5939717
• Report Number: 1722139-2015-00007
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: INF1200-A
• Device Catalogue Number: INF1200-A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/26/2015
• 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
• Treatment: NEOCATE JR.
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR
• Patient Weight: 24