PORTEX 100/199/075

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 2019-07-23 for PORTEX 100/199/075 manufactured by Smiths Medical Asd, Inc.

Event Text Entries

[152011434] It was reported that the customer identified a hole in the portex endotracheal tube after intubation. An emergent replacement was performed. No patient injury or complications were reported in relation to this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2019-03697
MDR Report Key8819633
Report SourceUSER FACILITY
Date Received2019-07-23
Date of Report2019-09-11
Date Mfgr Received2019-08-12
Date Added to Maude2019-07-23
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
Manufacturer G1SMITHS MEDICAL INTERNATIONAL LTD
Manufacturer StreetBOUNDARY ROAD
Manufacturer CityHYTHE,
Manufacturer CountryUK
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePORTEX
Generic NameTUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)
Product CodeCBI
Date Received2019-07-23
Catalog Number100/199/075
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
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 2019-07-23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.