CLEARLINK BLOOD RECIPIENT SET FNC1173

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 2019-11-13 for CLEARLINK BLOOD RECIPIENT SET FNC1173 manufactured by Baxter Healthcare Corporation.

Event Text Entries

[166867537] A batch review was conducted, and there were no deviations found related to this reported condition during the manufacture of this lot. The device was not received for evaluation. Therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[166867538] It was reported that the tubing of a clearlink y-type blood set, attached to the top of the filtered chamber, disconnected spontaneously, at the point of the drip chamber. The event occurred during a patient blood transfusion. 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 Number1416980-2019-06328
MDR Report Key9318461
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-13
Date of Report2019-11-13
Date of Event2019-10-18
Date Mfgr Received2019-10-18
Date Added to Maude2019-11-13
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 - SINGAPORE
Manufacturer Street2 WOODLANDS INDUSTRIAL PARK D
Manufacturer CitySINGAPORE 738750
Manufacturer CountrySN
Manufacturer Postal Code738750
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCLEARLINK BLOOD RECIPIENT SET
Generic NameSET, BLOOD TRANSFUSION
Product CodeBRZ
Date Received2019-11-13
Model NumberNA
Catalog NumberFNC1173
Lot NumberSR19C10032
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 2019-11-13

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