ARNDT ENDOBRONCHIAL BLOCKER SET C-AEBS-9.0-78-SPH-AS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other report with the FDA on 2020-01-29 for ARNDT ENDOBRONCHIAL BLOCKER SET C-AEBS-9.0-78-SPH-AS manufactured by Cook Inc.

Event Text Entries

[177370005] Pma/510(k) #: k160542. This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10


[177370006] It was reported that black spots were seen on an arndt endobronchial blocker set in two different places prior to opening the package. No patient contact was made. No adverse effects were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2020-00232
MDR Report Key9643427
Report SourceDISTRIBUTOR,FOREIGN,OTHER
Date Received2020-01-29
Date of Report2020-01-29
Date of Event2020-01-16
Date Mfgr Received2020-01-17
Device Manufacturer Date2019-10-15
Date Added to Maude2020-01-29
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 ContactUNK JENNIFER CANADA
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal47404
Manufacturer Phone8123392235
Manufacturer G1COOK INC
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal Code47404
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARNDT ENDOBRONCHIAL BLOCKER SET
Generic NameCBI TUBE, TRACHEAL/BRONCHIAL
Product CodeCBI
Date Received2020-01-29
Model NumberNA
Catalog NumberC-AEBS-9.0-78-SPH-AS
Lot Number10083573
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOOK INC
Manufacturer Address750 DANIELS WAY BLOOMINGTON IN 47404 US 47404


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-29

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