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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL NEB KIT W ADAPTER 0.45% NACL 1000ML; HUMIDIFIER NEBULIZER KIT
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VYAIRE MEDICAL NEB KIT W ADAPTER 0.45% NACL 1000ML; HUMIDIFIER NEBULIZER KIT Back to Search Results
Model Number NEB KIT W ADAPTER 0.45% NACL 1000ML
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/22/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).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 Description
The customer reported that the neb kit w adapter 0.45% nacl 1000ml experienced sputtering of water out of the tip of the bottle when mist stopped.As of this time, there is no information regarding patient involvement associated with the reported event.
 
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Brand Name
NEB KIT W ADAPTER 0.45% NACL 1000ML
Type of Device
HUMIDIFIER NEBULIZER KIT
Manufacturer (Section D)
VYAIRE MEDICAL
510 technology dr
irvine IL 92618
MDR Report Key12643922
MDR Text Key281096137
Report Number8030673-2021-00204
Device Sequence Number1
Product Code OGG
UDI-Device Identifier10190752152090
UDI-Public(01)10190752152090(10)0004177298
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial
Report Date 09/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberNEB KIT W ADAPTER 0.45% NACL 1000ML
Device Catalogue NumberCK4510
Device Lot Number0004177298
Was Device Available for Evaluation? No
Date Manufacturer Received09/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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