MAUDE Adverse Event Report: VYAIRE MEDICAL EXHALATION VALVE, 22ID 22OD STEM, ARM, AND 22MM OD PLUG

Model Number EXHALATION VALVE, 22ID 22OD STEM, ARM, AND 22MM OD PLUG

Device Problem Moisture or Humidity Problem (2986)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the suspect devices was no longer available, hence the reported device was not returned to the manufacturer.Investigation is ongoing.Any additional information received from the customer will be included in a follow-up report.

Event Description

The customer reported that the airlife exhalation valves were frequently disconnected from the exhalation line due to the short tapered connection and to the moisture build up on the device.The customer confirmed that no patient harm was associated on this event, however this may lead to patient injury due to under ventilation.The customer also reported that replacement of a new line was necessary on every circuit change.In order for the tubing to have clean end, clipping was also performed on every disconnection of the device.The customer reported that the event occurred on several instances on 22 devices during and after patient use; and confirmed that no patient harm was associated on this event.The suspect devices were replaced and alternate exhalation valves were used.

• Brand Name: EXHALATION VALVE, 22ID 22OD STEM, ARM, AND 22MM OD PLUG
• Type of Device: EXHALATION VALVE
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada via de la produccion; 85 industrial mexicali; mexicali, 21397 ; MX 21397
• Manufacturer Contact: stanley tan ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149193324
• MDR Report Key: 9512208
• MDR Text Key: 219571026
• Report Number: 8030673-2019-00060
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EXHALATION VALVE, 22ID 22OD STEM, ARM, AND 22MM OD PLUG
• Device Catalogue Number: 004379
• Device Lot Number: 0000318408 & 0000353988
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1