MAUDE Adverse Event Report: MOOG MEDICAL DEVICES GROUP INFINITY ADMINISTRATION SET; ENTERAL INFUSION PUMP AND ACCESORY SETS

Model Number NOT PROVIDED

Device Problem Failure to Auto Stop (2938)

Patient Problem Abdominal Distention (2601)

Event Date 10/16/2016

Event Type  malfunction  

Manufacturer Narrative

This device was not returned to mmdg for evaluation.Because the set was not returned, no investigation was performed and mmdg was unable to confirm the complaint.

Event Description

Mmdg received a medwatch notice (b)(4) stating that a patient had been hospitalized due to the infinity administration set allowed air into the patients stomach.They alledge that the cap on the bag does not completely seal, allowing extra air to enter the bag, move through the formula and then enter the patients stomach via her g-tube.They state that the patient has experienced excess gas, distention in her stomach and pain in her g-tube site related to the extra air.Mmdg was not provided with any contact information and therefore, was not able to follow up with the initial reporter and check up on the patients condition.

• Brand Name: INFINITY ADMINISTRATION SET
• Type of Device: ENTERAL INFUSION PUMP AND ACCESORY 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: 6130026
• MDR Text Key: 60994179
• Report Number: 1722139-2016-00606
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: NOT PROVIDED
• Device Catalogue Number: NOT PROVIDED
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/29/2016
• Initial Date FDA Received: 11/28/2016
• 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 Outcome(s): Hospitalization