PORTEX? BIVONA? ADULT TTS? TRACHEOSTOMY TUBE 670170

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 2020-03-27 for PORTEX? BIVONA? ADULT TTS? TRACHEOSTOMY TUBE 670170 manufactured by Smiths Medical Asd; Inc..

Event Text Entries

[185482094] Information was received indicating that 10 days following placement of a smiths medical portex? Bivona? Adult tts? Tracheostomy (trach) tube, the patient had breathing difficulties. Subsequently, the trach tube was changed out and the patient recovered. It was reported that a hole was found in the cuff. There were no further adverse effects.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2020-02381
MDR Report Key9892388
Report SourceDISTRIBUTOR
Date Received2020-03-27
Date of Report2020-03-27
Date of Event2020-01-13
Date Mfgr Received2020-02-27
Device Manufacturer Date2019-08-20
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 ASD; INC.
Manufacturer Street6000 NATHAN LANE N
Manufacturer CityMINNEAPOLIS,, MN
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePORTEX? BIVONA? ADULT TTS? TRACHEOSTOMY TUBE
Generic NameTUBE TRACHEOSTOMY AND TUBE CUFF
Product CodeJOH
Date Received2020-03-27
Returned To Mfg2020-03-25
Model Number670170
Catalog Number670170
Lot Number3856200
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD; INC.
Manufacturer Address6000 NATHAN LANE N MINNEAPOLIS,, MN US


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Required No Informationntervention 2020-03-27

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