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 2020-03-05 for CLEARLINK CONTINU-FLO BLOOD RECIPIENT SET FNC3220N manufactured by Baxter Healthcare Corporation.

Event Text Entries

[182294075] Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[182294076] It was reported that there was blood backflow in the line all the way to the bung/access of a clearlink continu-flo blood recipient set. It was further reported that the bung/access had "fallen through or almost disintegrated. " this issue was identified during patient infusion with cephazolin. There was no patient injury or medical intervention associated with this event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1416980-2020-01237
MDR Report Key9796041
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-05
Date of Report2020-03-05
Date of Event2020-02-11
Date Mfgr Received2020-02-12
Date Added to Maude2020-03-05
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 Received2020-03-05
Model NumberNA
Catalog NumberFNC3220N
Lot Number1918T731
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE CORPORATION
Manufacturer AddressDEERFIELD IL


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-05

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