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 Information (3190)
Date of Event	07/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire identification number: (b)(4).At this time, vyaire has not received the suspect device/component for evaluation.The device history record (dhr) of the device was reviewed in order to detect any issue related with the defect reported by the customer during its manufacturing.There were no issues found after review.No root cause could be determined.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.The respiratory therapist suggested that the long stem on the adaptor kits was not allowing the mist to form.At this time, there was no information on patient involvement in this reported event.

• Brand Name: NEB KIT W ADAPTER STERILE WATER 1000ML
• Common Device Name: HUMIDIFIER NEBULIZER KIT
• MDR Report Key: 10382896
• Report Number: 8030673-2020-00114
• Device Sequence Number: 2572121
• Product Code: OGG
• UDI-Device Identifier: 10885403199141
• UDI-Public: (01)10885403199141(10)0004123909
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2020

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: NEB KIT W ADAPTER STERILE WATER 1000ML
• Device Catalogue Number: CK0010
• Device Lot Number: 0004123909
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 08/07/2020
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1