SMITHS MEDICAL PORTEX ENDOBRONCHIAL TUBE 198-37L

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-08-29 for SMITHS MEDICAL PORTEX ENDOBRONCHIAL TUBE 198-37L manufactured by Smiths Medical Asd, Inc..

Event Text Entries

[156019374] Information was received that a crack in the bronchial-sidefiber cap was noted on a smiths medical endobronchial tube. Incident was reported to have occurred prior to use with a patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2019-04624
MDR Report Key8946309
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-08-29
Date of Report2019-10-22
Date of Event2019-08-02
Date Mfgr Received2019-09-23
Device Manufacturer Date2019-04-15
Date Added to Maude2019-08-29
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 Phone7633833310
Manufacturer G1SMITHS MEDICAL, ASD INC.
Manufacturer StreetBOUNDARY ROAD
Manufacturer CityKENT,
Manufacturer CountryUK
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSMITHS MEDICAL PORTEX ENDOBRONCHIAL TUBE
Generic NameTUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)
Product CodeCBI
Date Received2019-08-29
Returned To Mfg2019-08-09
Catalog Number198-37L
Lot Number3771502
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD, INC.
Manufacturer Address6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-29

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