MAUDE Adverse Event Report: NEB ADAPTER F/1000ML BOTTLE 24/CS; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number	NEB ADAPTER F/1000ML BOTTLE 24/CS
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
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
The customer reported a clogged nebulizer cap that wouldn't nebulize, and apparently a couple others have been reported as being sluggish in terms of aerosol output/sputtering.
Additional Manufacturer Narrative
The customer sent one opened sample part number (b)(4).With lot number 0004170351 within original package for the investigation.Sample was inspected according to pqas ck0005 etal performing a vacuum test, diameter verification, bar gage verification, cap - bottle installation test, getting acceptable results.Therefore the defect reported by the customer was not confirmed.

• Brand Name: NEB ADAPTER F/1000ML BOTTLE 24/CS
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• MDR Report Key: 11721220
• Report Number: 8030673-2021-00164
• Device Sequence Number: 19837939
• Product Code: CCK
• UDI-Device Identifier: 10885403180477
• UDI-Public: (01)10885403180477(10)0004170351
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K112840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2021

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: NEB ADAPTER F/1000ML BOTTLE 24/CS
• Device Catalogue Number: 3D0868
• Device Lot Number: 0004170351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 05/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1