PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-02-09 for PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE manufactured by Smiths Medical Asd, Inc..

Event Text Entries

[178325045] Report source: (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[178325046] Information was received that clamp that secures the tube on a smiths medical portex adjustable flange tracheostomy tube was not holding and loosened. Patient was in distress. Unplanned tracheostomy performed. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2020-00956
MDR Report Key9685107
Report SourceFOREIGN,USER FACILITY
Date Received2020-02-09
Date of Report2020-02-09
Date of Event2020-01-01
Date Mfgr Received2020-01-10
Date Added to Maude2020-02-09
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 55442
Manufacturer CountryUS
Manufacturer Postal55442
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE
Generic NameTUBE, TRACHEOSTOMY (W/WO CONNECTOR) PRODUCT CODE: BTO
Product CodeBTO
Date Received2020-02-09
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD, INC.
Manufacturer Address6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-02-09

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