MAUDE Adverse Event Report: VYAIRE MEDICAL NEB KIT W ADAPTER STERILE WATER 1000ML; PREFILLED AND DRY LARGE VOLUME NEBULIZER

Model Number NEB KIT W ADAPTER STERILE WATER 1000ML

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2021

Event Type  malfunction  

Event Description

The customer reported that the neb kit w adapter sterile water 1000ml experienced sterile water spitting out from the water and entering the corrugated tubing that is attached to the patient.The customer confirmed that there was no patient harm associated with the reported event.

Manufacturer Narrative

The suspect device has not been returned for evaluation.The customer stated that it was already disposed as this is potentially infectious.Therefore, no root cause could be determined.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.

• Brand Name: NEB KIT W ADAPTER STERILE WATER 1000ML
• Type of Device: PREFILLED AND DRY LARGE VOLUME NEBULIZER
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada via de la produccion; no. 85, parque undustrial mex; mexicali, ; MX
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 12780829
• MDR Text Key: 280538212
• Report Number: 8030673-2021-00209
• Device Sequence Number: 1
• Product Code: OGG
• UDI-Device Identifier: 10190752158450
• UDI-Public: (01)10190752158450(10)4138942
• Combination Product (y/n): N
• Reporter Country Code: RP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEB KIT W ADAPTER STERILE WATER 1000ML
• Device Catalogue Number: CK0010
• Device Lot Number: 4138942
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1