CLEARLINK CONTINU-FLO BLOOD RECIPIENT SET FNC3220N

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 2019-11-20 for CLEARLINK CONTINU-FLO BLOOD RECIPIENT SET FNC3220N manufactured by Baxter Healthcare Corporation.

MAUDE Entry Details

Report Number1416980-2019-06454
MDR Report Key9350514
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-20
Date of Report2019-11-20
Date Mfgr Received2019-10-25
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
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street25212 W. ILLINOIS ROUTE 120
Manufacturer CityROUND LAKE IL 60073
Manufacturer CountryUS
Manufacturer Postal60073
Manufacturer Phone2242702068
Manufacturer G1BAXTER HEALTHCARE - MALTA
Manufacturer StreetA47 INDUSTRIAL ESTATE
Manufacturer CityMARSA
Manufacturer CountryMT
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCLEARLINK CONTINU-FLO BLOOD RECIPIENT SET
Generic NameSET, BLOOD TRANSFUSION
Product CodeBRZ
Date Received2019-11-20
Model NumberNA
Catalog NumberFNC3220N
Lot NumberASKU
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE CORPORATION
Manufacturer AddressDEERFIELD IL


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-20

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