MAUDE Adverse Event Report: MOOG MEDICAL DEVICES GROUP BAG SET, 1200ML, ENFITCONNECTOR; ENTERAL FEEDING SET

Model Number INF1200-A

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

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

Event Date 08/12/2015

Event Type  malfunction  

Manufacturer Narrative

The complainant did not return the device for evaluation.A dhr review was performed on lot #cf1513509 no ncrs were issued during the original build.

Event Description

The initial reporter stated: feeding bag full of formula when nurse arrived in the morning indicating patient did not receive overnight enteral feedings.Pump stated all feedings were given.A brand new pump was delivered to the home on monday, (b)(4) 2015.On afternoon of (b)(6) 2015, noted feedings had not infused after 4 hours when initially started and had to remove white transition piece to prime feeding bag and then reconnect to extension to start feeding.(b)(4).

• Brand Name: BAG SET, 1200ML, 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: 5503639
• MDR Text Key: 40411268
• Report Number: 1722139-2016-00360
• 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
• 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: 03/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 05/15/2018
• Device Model Number: INF1200-A
• Device Catalogue Number: INF1200-A
• Device Lot Number: CF1513509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2015
• 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