RUSCH DOUBLE LUMEN BRONCHIAL TUBE SET LEFT 116100-000370

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 2019-11-04 for RUSCH DOUBLE LUMEN BRONCHIAL TUBE SET LEFT 116100-000370 manufactured by Teleflex Medical.

MAUDE Entry Details

Report Number8040412-2019-00306
MDR Report Key9271579
Report SourceFOREIGN,USER FACILITY
Date Received2019-11-04
Date of Report2019-10-12
Date of Event2019-06-10
Date Mfgr Received2019-10-12
Date Added to Maude2019-11-04
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 ContactVICTORIA SANDLIN
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer G1TELEFLEX MEDICAL
Manufacturer StreetPO BOX 28, KAMUNTING INDUSTRIAL ESTATE
Manufacturer CityPERAK, WEST MALAYSIA 34600
Manufacturer CountryMY
Manufacturer Postal Code34600
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRUSCH DOUBLE LUMEN BRONCHIAL TUBE SET LEFT
Generic NameTUBE, BRONCHIAL (W/WO CONNECT
Product CodeBTS
Date Received2019-11-04
Catalog Number116100-000370
Lot Number18IT23
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressATHLONE


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-04

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