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 health professional,user faci report with the FDA on 2017-11-28 for CONNECTOR U/ADAPIT STR 22MM ID X 22MM OD 004081-A manufactured by Vyaire Medical, Inc.

Event Text Entries

[93109645] Initial emdr submission: sample is available, ups shipping labels provided to customer to have the sample returned. Currently awaiting for the sample. Once the investigation is complete a follow up submission will be filed.
Patient Sequence No: 1, Text Type: N, H10


[93109646] We have begun to investigate all our patients with this adapter and o2 with sleep equipment to visually inspect all equipment. We have since found 2 more patients and incidence of melted adapters.
Patient Sequence No: 1, Text Type: D, B5


[109798338] Sample available. However based on the customer stating the product was in use for 1 year and 5 days, our ifu states this product should not be used longer than 30 days as the product can become deformed or discolored. The customer has been provided the ifu and instructed on the proper use of the device.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number8030673-2017-00389
MDR Report Key7064125
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2017-11-28
Date of Report2017-12-11
Date of Event2017-11-21
Date Mfgr Received2017-12-01
Date Added to Maude2017-11-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRESPIRATORY THERAPIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMINDY FABER
Manufacturer Street26125 N RIVERWOODS 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 Received2017-11-28
Catalog Number004081-A
OperatorRESPIRATORY THERAPIST
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerVYAIRE MEDICAL, INC
Manufacturer Address26125 N RIVERWOODS BLVD METTAWA IL 60045 US 60045


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-11-28

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