MAUDE Adverse Event Report: NEB KIT W ADAPTER STERILE WATER 1000ML; HUMIDIFIER NEBULIZER KIT

Model Number	NEB KIT W ADAPTER STERILE WATER 1000ML
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
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.Pma/ 510(k): enforcement discretion.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 our ck0010 neb kit w adapter sterile water 1000ml was not misting.There was no patient harm.
Additional Manufacturer Narrative
The device was not returned for analysis however customer sent some pictures.Visual inspection shows a bottle with the part number cn0010 and a label with the printed lot number 0004150098.No defects were seen in the pictures provided.The defect reported by the customer was not confirmed.

• Brand Name: NEB KIT W ADAPTER STERILE WATER 1000ML
• Common Device Name: HUMIDIFIER NEBULIZER KIT
• MDR Report Key: 12424979
• Report Number: 8030673-2021-00192
• Device Sequence Number: 19748284
• Product Code: OGG
• UDI-Device Identifier: 10885403221484
• UDI-Public: (01)10885403221484
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2021

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 KIT W ADAPTER STERILE WATER 1000ML
• Device Catalogue Number: CK0010
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/06/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 10/05/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1