PLEURX PERITONEAL CATHETER MINI KIT 50-9050

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-11-20 for PLEURX PERITONEAL CATHETER MINI KIT 50-9050 manufactured by Carefusion, Inc.

MAUDE Entry Details

Report Number1625685-2019-00129
MDR Report Key9351498
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2019-11-20
Date of Report2019-11-20
Date of Event2019-11-11
Date Mfgr Received2019-11-14
Date Added to Maude2019-11-20
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 PERITONEAL CATHETER MINI KIT
Generic NamePERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING
Product CodePNG
Date Received2019-11-20
Catalog Number50-9050
Lot NumberUNKNOWN
OperatorLAY USER/PATIENT
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCAREFUSION, INC
Manufacturer Address75 N. FAIRVIEW DRIVE VERNON HILLS IL 60061 US 60061


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-11-20

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