MAUDE Adverse Event Report: MOOG MOOG PRODUCT ; CONNECTOR SYSTEM

Model Number INF1200-A

Device Problems Crack (1135); Fail-Safe Design Failure (1222); Leak/Splash (1354); Insufficient Flow or Under Infusion (2182)

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

Event Date 01/06/2016

Event Type  malfunction  

Event Description

I use a moog enteralite infinity pump for my g-tube feedings and have recently changed to the "1200 ml enteralite pump delivery sets with enfit connector system and transitional stepped connector" (moog product # inf 1200-a, lot # 2018-02-03 cf1500210).My experience with the enfit connectors is that i have had a failure rate of around 20% where the fittings crack and leak.I have contacted the mfr, but their replies don't show that they recognize the problem, nor do they appear to be doing anything to correct the issue.The enfit design may be part of the problem as well as material choices that result in multiple failures.In addition to the leaks, the smaller bore size means slower feed rates and the deep recesses in the female half of the connector are impossible to clean, so there is also an increased risk of food borne illness.I recognize that the intent of the new design was to prevent mis-connections with other systems, but this new design is a step backwards for my quality of life and needs rethought to improve the life of tube feeders.Thanks for your help with addressing this issue.

• Brand Name: MOOG PRODUCT
• Type of Device: CONNECTOR SYSTEM
• Manufacturer (Section D): MOOG; salt lake city UT
• MDR Report Key: 5357959
• MDR Text Key: 35660211
• Report Number: MW5059160
• Device Sequence Number: 1
• Product Code: PIF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/03/2018
• Device Model Number: INF1200-A
• Device Lot Number: 2018-02-03 CF1500210
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 70