MAUDE Adverse Event Report: VYAIRE MEDICAL FAST NEB W/TEE ADAPTER, 84" TUBING¿; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number	FAST NEB W/TEE ADAPTER, 84" TUBING
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer stated no samples available for return.No photos taken of the leaking nebulizer, therapists disposed of them after the treatments.Multiple occurrences reported by various therapists of leaking medication from the nebulizer, lot numbers the same 0004119713.Any additional information received from the customer will be included in a follow-up report.
Event or Problem Description
The customer reported that the fast neb w/tee adapter, 84" tubing is leaking medication during patient use.The customer confirmed no harm occurred to the patient.

• Brand Name: FAST NEB W/TEE ADAPTER, 84" TUBING¿
• Common Device Name: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 9851226
• Report Number: 8030673-2020-00085
• Device Sequence Number: 3432167
• Product Code: CAF
• UDI-Device Identifier: 10885403193255
• UDI-Public: (01)10885403193255(10)0004119713
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/17/2020

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: FAST NEB W/TEE ADAPTER, 84" TUBING
• Device Catalogue Number: FN2438
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1