PVC - PORTEX TUBES BLUE LINE CLASSIC 100/515/075

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-25 for PVC - PORTEX TUBES BLUE LINE CLASSIC 100/515/075 manufactured by Smiths Medical Asd,inc.

Event Text Entries

[185000513] Information received a smiths medical tracheostomy
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2020-02242
MDR Report Key9881214
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-25
Date of Report2020-03-25
Date of Event2020-02-04
Date Mfgr Received2020-02-25
Date Added to Maude2020-03-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactDAVE HALVERSON
Manufacturer Street6000 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 NamePVC - PORTEX TUBES BLUE LINE CLASSIC
Generic NameTUBE TRACHEOSTOMY AND TUBE CUFF
Product CodeJOH
Date Received2020-03-25
Returned To Mfg2020-02-28
Catalog Number100/515/075
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD,INC
Manufacturer Address6000 NATHAN LANE MINNEAPOLIS, MN US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-25

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