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,consum report with the FDA on 2020-03-03 for CLEARLINK CONTINU-FLO BLOOD RECIPIENT SET FNC3220N manufactured by Baxter Healthcare Corporation.

Event Text Entries

[181922988] (b)(6). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[181922989] It was reported that the tubing of a continu-flo blood/solution set was cut near the y-site of the clearlink. The cut tubing was discovered in the packaging 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 Number1416980-2020-01158
MDR Report Key9782421
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2020-03-03
Date of Report2020-04-02
Date of Event2020-02-06
Date Mfgr Received2020-03-30
Device Manufacturer Date2019-08-02
Date Added to Maude2020-03-03
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 - TUNISIA
Manufacturer StreetROUTE DE CHEBBAOU 2021OUED E
Manufacturer CityTUNIS
Manufacturer CountryTS
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 Received2020-03-03
Returned To Mfg2020-03-04
Model NumberNA
Catalog NumberFNC3220N
Lot Number19H09T433
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE CORPORATION
Manufacturer AddressDEERFIELD IL


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-03

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