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 company representative,foreig report with the FDA on 2020-01-24 for RUSCH DOUBLE LUMEN BRONCHIAL TUBE SET LEFT 116100-000370 manufactured by Teleflex Medical.

Event Text Entries

[183754031] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[183754032] Customer complaint reported as: "when unpacking before the operation, the angle connector of the tube is broken off before use. " no patient involvement reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8040412-2020-00016
MDR Report Key9626898
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-01-24
Date of Report2020-01-10
Date of Event2020-01-01
Date Mfgr Received2020-02-28
Date Added to Maude2020-01-24
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 ContactKATHARINE TARPLEY
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9194334854
Manufacturer G1TELEFLEX MEDICAL SDN. BHD.
Manufacturer StreetLOT NO : PT2577 JALEN PERUSAHAAN 4 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 Received2020-01-24
Returned To Mfg2020-02-12
Catalog Number116100-000370
Lot Number19IT37
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressATHLONE


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-24

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