MAUDE Adverse Event Report: VYAIRE MEDICAL NASOGASTRIC PRESSURE MONITORING TUBE SET,16FR ADULT; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	VMAX ENCORE 22DNASOGASTRIC PRESSURE MONITORING TUBE SET,16FR ADULT
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
It was reported to vyaire medical that the liquid nutrient was fed into an avea nasogastric pressure monitoring tube set, liquid leak at the bottom end of the clear sleeve which holds three tubes together was observed (three tubes are for gas, liquid and pressure monitoring).

• Brand Name: NASOGASTRIC PRESSURE MONITORING TUBE SET,16FR ADULT
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 11599999
• Report Number: 2021710-2021-13592
• Device Sequence Number: 11642961
• Product Code: CBK
• UDI-Device Identifier: 10846446002683
• UDI-Public: (01)10846446002683(10)BA1211
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K942211
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2021

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
• Operator of Device: Health Professional
• Device Model Number: VMAX ENCORE 22DNASOGASTRIC PRESSURE MONITORING TUBE SET,16FR ADULT
• Device Catalogue Number: 3001042
• Device Lot Number: BA1211
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1