BIVONA? ADULT TTS? TRACHEOSTOMY TUBE CUSTOM 4.0 FLEXTEND TTS NS +1/EA 60PFP60

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2020-03-26 for BIVONA? ADULT TTS? TRACHEOSTOMY TUBE CUSTOM 4.0 FLEXTEND TTS NS +1/EA 60PFP60 manufactured by Smiths Medical Asd,inc..

Event Text Entries

[185197277] Information was received that smiths bivona? Adult tts? Tracheostomy tracheostomy
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2020-02259
MDR Report Key9887056
Report SourceCONSUMER,HEALTH PROFESSIONAL,
Date Received2020-03-26
Date of Report2020-03-26
Date Mfgr Received2020-02-26
Date Added to Maude2020-03-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactDAVE HALVERSON
Manufacturer Street6000 NATHAN LANE NORTH
Manufacturer CityMINNEAPOLIS, MN
Manufacturer CountryUS
Manufacturer Phone3833310
Manufacturer G1SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
Manufacturer StreetAVE CALIDAD NO. 4, PARQUE INDUSTRIAL INTERNACIONA
Manufacturer CityTIJUANA, B.C. 22425
Manufacturer CountryMX
Manufacturer Postal Code22425
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBIVONA? ADULT TTS? TRACHEOSTOMY TUBE
Generic NameTUBE TRACHEOSTOMY AND TUBE CUFF
Product CodeJOH
Date Received2020-03-26
Returned To Mfg2020-03-25
Model NumberCUSTOM 4.0 FLEXTEND TTS NS +1/EA
Catalog Number60PFP60
Lot NumberUNKNOWN
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD,INC.
Manufacturer Address6000 NATHAN LANE NORTH MINNEAPOLIS, MN US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-26

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