CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET UC8519

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET UC8519 manufactured by Baxter Healthcare Corporation.

Event Text Entries

[185900580] (b)(6). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[185900581] It was reported that two (2) clearlink system continu-flo solution sets were severed. The cut in the set was discovered prior to patient use. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1416980-2020-01879
MDR Report Key9908042
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-05
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
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 91000
Manufacturer CountryDR
Manufacturer Postal Code91000
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET
Generic NameSET, ADMINISTRATION, INTRAVASCULAR
Product CodeFPA
Date Received2020-03-31
Model NumberNA
Catalog NumberUC8519
Lot NumberDR20A20051
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 2020-03-31

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