PORTEX BIVONA TRACHEOSTOMY TUBE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-27 for PORTEX BIVONA TRACHEOSTOMY TUBE manufactured by Smiths Medical Asd; Inc..

Event Text Entries

[185193308] Information was received indicating that the cuff to a smiths medical portex bivona tracheostomy tube is failing and damaged. There were no reported adverse effects.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2020-02239
MDR Report Key9887341
Report SourceUSER FACILITY
Date Received2020-03-27
Date of Report2020-03-25
Date of Event2020-02-25
Date Mfgr Received2020-02-25
Date Added to Maude2020-03-27
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 N
Manufacturer CityMINNEAPOLIS,, MN
Manufacturer CountryUS
Manufacturer Phone3833310
Manufacturer G1SMITHS MEDICAL INTERNATIONAL LTD.
Manufacturer StreetBOUNDARY ROAD
Manufacturer CityHYTHE, KENT CT216JL
Manufacturer CountryUK
Manufacturer Postal CodeCT21 6JL
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePORTEX BIVONA TRACHEOSTOMY TUBE
Generic NameTUBE TRACHEOSTOMY AND TUBE CUFF
Product CodeJOH
Date Received2020-03-27
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD; INC.
Manufacturer Address6000 NATHAN LANE N MINNEAPOLIS,, MN US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-27

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