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 10/21/2015

Event Type  malfunction  

Manufacturer Narrative

The complainant did not return the device for evaluation.A dhr review was performed on lot#cf1517010 no defects were found and no ncrs were issued during the original build.

Event Description

The initial reporter stated: bag set stops working, pump shows running but formula will not flow.Sometimes she has to change bags as often as twice before the feeding can be completed" gender of child provided during the conversation, but when asked she would not provide his age, weight or diagnosis - said it was pertinent.Dose and formula were given: 115 ml/hour for a total of 1350 ml of neocate jr power mixed with pedialyte.She threw away the last bag where this occured but said she would send on when it happens again.[complaint-(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: 5503116
• MDR Text Key: 40392872
• Report Number: 1722139-2016-00361
• 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: consumer
• 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
• Device Expiration Date: 06/19/2018
• Device Model Number: INF1200-A
• Device Catalogue Number: INF1200-A
• Device Lot Number: CF1517010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2015
• 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
• Treatment: PEDIALYTE