CLEARLINK BLOOD RECIPIENT SET 2C8750

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-10-11 for CLEARLINK BLOOD RECIPIENT SET 2C8750 manufactured by Baxter Healthcare - Dominican Republic.

MAUDE Entry Details

Report Number1416980-2019-05576
MDR Report Key9182748
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-10-11
Date of Report2019-11-14
Date of Event2019-09-18
Date Mfgr Received2019-10-31
Device Manufacturer Date2019-04-25
Date Added to Maude2019-10-11
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 - DOMINICAN REPUBLIC
Manufacturer StreetCARRETERA SANCHEZ KM 18.5 PARQUE INDUSTRIAL ITABO, PIISA
Manufacturer CityHAINA SAN CRISTOBAL
Manufacturer CountryDR
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCLEARLINK BLOOD RECIPIENT SET
Generic NameSET, BLOOD TRANSFUSION
Product CodeBRZ
Date Received2019-10-11
Returned To Mfg2019-10-22
Model NumberNA
Catalog Number2C8750
Lot NumberDR19F24022
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE - DOMINICAN REPUBLIC
Manufacturer AddressHAINA SAN CRISTOBAL


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.