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

Model Number INF0500-A

Device Problem Free or Unrestricted Flow (2945)

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

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to mmdg, and therefore mmdg could not perform an investigation.No lot number was provided and therefore, no dhr could be completed.This report will be updated if any additional information is made available.

Event Description

The initial reporter stated that they had bags that "once formula was poured into bag it immediately started flowing".Mmdg did follow up with the initial reporter who stated that the patient was doing well and there had been no adverse events associated with the complaint.(b)(4).

• Brand Name: BAG SET, 500ML, ENFITCONNECTOR
• 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, SRL; coyol free zone and; business park; alajuela, san jose 20113 ; CS 20113
• Manufacturer Contact: kristin hardesty ; 4314 zevex park lane; salt lake city, UT 84123 ; 8012641001
• MDR Report Key: 7561602
• MDR Text Key: 109898079
• Report Number: 1722139-2018-00148
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: INF0500-A
• Device Catalogue Number: INF0500-A
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/03/2018
• 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: Unknown
• Patient Sequence Number: 1