MAUDE Adverse Event Report: MOOG MEDICAL DEVICES GROUP BAG SET, 500ML, ENFITCONNECTOR; ENTERAL FEEDING SET

Model Number INF0500-A

Device Problems Failure to Sense (1559); Failure to Infuse (2340)

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

Event Date 08/30/2015

Event Type  malfunction  

Manufacturer Narrative

The complainant did not return the device for investigation.A review of the dhr was performed and no non-conformances were issued during the original build.

Event Description

Customer states: family/nursing have delivered mixture of water, elecare jr.And green beans for years same recipe, rate, etc without issues.Nurse reports recently, the teal portion of the tubing is becoming clogged.Nursing has been pulling the tubing off the cassette, cleaning and reattaching.The nurse feels that something has changed inside the tubing as this has happened frequently over the past week.She also notes that they received feeding bags, however unsure if these are the new or old bags.Nurse also reports they are no longer receiving "no flow out alarms" when the tubing is plugged.Pump was exchanged but nurse manager could not duplicate issue.(b)(4).

• Brand Name: BAG SET, 500ML, ENFITCONNECTOR
• 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: matt brinkerhoff ; 4314 zevex park lane; salt lake city, UT 84123 ; 8012641001
• MDR Report Key: 5503119
• MDR Text Key: 40395425
• Report Number: 1722139-2016-00368
• 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: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Expiration Date: 05/29/2018
• Device Model Number: INF0500-A
• Device Catalogue Number: INF0500-A
• Device Lot Number: CF1514906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Weight: 16