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

Model Number INF0500-A

Device Problem Leak/Splash (1354)

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

Event Date 06/02/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to mmdg for evaluation.A dhr could not be completed because no lot number was provided.Because the device was not returned, mmdg has been unable to investigate or confirm the complaint.This report will be updated if the device is returned to mmdg.

Event Description

The initial reporter states that the administration set had a hole in it.They stated that they had run out of bags and had to use the same bag for a week because their homecare provider never delivered their supplies.They stated that eventually the teal loop on the administration set had a hole worn into it and that they had to take the patient to the hospital to receive feeding.This resulted in an 11 hour delay of therapy.Mmdg followed up with the initial reporter, who stated that the patient had experienced dehydration, but was discharged from the hospital.They had also been instructed on how to provide supplemental feeding while they waited for supplies to be delivered.(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
• Manufacturer (Section G): MOOG MEDICAL DEVICES GROUP, SRL; coyol free zone and; business park; alajuela, 20113 ; CS 20113
• Manufacturer Contact: kristin hardesty ; 4314 zevex park lane; salt lake city, ut ; 2641001112
• MDR Report Key: 10208371
• MDR Text Key: 197845960
• Report Number: 1722139-2020-00273
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• 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
• Date Manufacturer Received: 06/02/2020
• 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
• Patient Age: 9 MO