CONNECTOR U/ADAPIT STR 22MM ID X 22MM OD 004081-A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-02-12 for CONNECTOR U/ADAPIT STR 22MM ID X 22MM OD 004081-A manufactured by Vyaire Medical, Inc.

Event Text Entries

[99777155] (b)(4): vyaire will reach out to customer for sample availability and additional information. If the sample is obtained and further evaluation can be performed an update emdr will be provided.
Patient Sequence No: 1, Text Type: N, H10


[99777156] The customer reported "we are experiencing melting of the cardinal health o2 bleed-in adapter with use of a bi level humidifier. We cannot replicate this in our test environment. The melting is happening at the nipple and what is most notable is the tapering of the port that restricts the flow of oxygen".
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8030673-2018-00411
MDR Report Key7262957
Report SourceDISTRIBUTOR
Date Received2018-02-12
Date of Report2018-02-12
Date of Event2018-02-02
Date Mfgr Received2018-02-05
Date Added to Maude2018-02-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMINDY FABER
Manufacturer Street26125 N RIVERWOOD BLVD
Manufacturer CityMETTAWA IL 60045
Manufacturer CountryUS
Manufacturer Postal60045
Manufacturer G1VYAIRE MEDICAL, INC
Manufacturer StreetCERRADA VIA DE LA PRODUCCION NO. 85 PARQUE INDUSTRIAL MEX
Manufacturer CityMEXICALI BAJA CALIFORNIA NORTE
Manufacturer CountryMX
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCONNECTOR U/ADAPIT STR 22MM ID X 22MM OD
Generic NameCONNECTOR, AIRWAY (EXTENSION)
Product CodeBZA
Date Received2018-02-12
Catalog Number004081-A
Lot Number0001129863
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerVYAIRE MEDICAL, INC
Manufacturer Address26125 N RIVERQWOOD METTAWA IL 60045 US 60045


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-02-12

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