MAUDE Adverse Event Report: VYAIRE MEDICAL NEB ADAPTER F/1000ML BOTTLE; NEBULIZER ADAPTER

Model Number	3D0868
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical complaint number: (b)(4).At this time, vyaire medical has not received the suspect device for evaluation.
Event or Problem Description
Customer reported: as per rt, supplies for high humidity face mask oxygen delivery required for treatment.Airlife nebulizer cap required for treatment, retrieved with sterile water bottle.Given to rt.Rt informed staff that supplies did not fit together.Second bottle retrieved.Still did not fit.Second airlife nebulizer cap retrieved, also did not fit.Staff had to go to for a third airlife nebulizer cap and sterile water bottle.

• Brand Name: NEB ADAPTER F/1000ML BOTTLE
• Common Device Name: NEBULIZER ADAPTER
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 8466073
• Report Number: 8030673-2019-00036
• Device Sequence Number: 13788457
• Product Code: CAF
• UDI-Device Identifier: 10885403180477
• UDI-Public: (01)10885403180477(10)0001201314
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: OBSOLETE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3D0868
• Device Catalogue Number: 3D0868
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other