DUO-VENT CLEARLINK LUER ACTIVATED VALVE 2C8875

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 2020-03-31 for DUO-VENT CLEARLINK LUER ACTIVATED VALVE 2C8875 manufactured by Baxter Healthcare Corporation.

Event Text Entries

[185779987] (b)(4). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[185779988] It was reported that an unspecified quantity of clearlink system solution sets were discovered to have cut tubing which resulted in leakage of solution. During an unspecified process step, the customer observed that there was a fracture in the line which resulted in leakage of etoposide chemotherapy. It was unknown if there was patient involvement. There was no report of 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 Number1416980-2020-01880
MDR Report Key9905540
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
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 - CARTAGO
Manufacturer StreetSEE H10 SEE H10
Manufacturer CityCARTAGO 30106
Manufacturer CountryCS
Manufacturer Postal Code30106
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDUO-VENT CLEARLINK LUER ACTIVATED VALVE
Generic NameSET, ADMINISTRATION, INTRAVASCULAR
Product CodeFPA
Date Received2020-03-31
Model NumberNA
Catalog Number2C8875
Lot NumberR19J08036
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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