PLEURX PLEURAL MINI-KIT 50-7050

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2020-03-31 for PLEURX PLEURAL MINI-KIT 50-7050 manufactured by Carefusion, Inc.

MAUDE Entry Details

Report Number1625685-2020-00035
MDR Report Key9908560
Report SourceCOMPANY REPRESENTATIVE,OTHER
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-03
Date Mfgr Received2020-03-06
Date Added to Maude2020-03-31
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 ContactBDX ANNA WEHRHEIM
Manufacturer Street75 N. FAIRVIEW DRIVE
Manufacturer CityVERNON HILLS IL 60061
Manufacturer CountryUS
Manufacturer Postal60061
Manufacturer Phone8015652341
Manufacturer G1CAREFUSION, INC
Manufacturer Street400 EAST FOSTER RD
Manufacturer CityMANNFORD OK 74044
Manufacturer CountryUS
Manufacturer Postal Code74044
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePLEURX PLEURAL MINI-KIT
Generic NameAPPARATUS, SUCTION, PATIENT CARE
Product CodeDWM
Date Received2020-03-31
Catalog Number50-7050
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCAREFUSION, INC
Manufacturer Address400 EAST FOSTER RD MANNFORD OK 74044 US 74044


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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