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PLEXITRON SOLUTION ADMINISTRATION SETS Adverse Event — Malfunction (MDR 1416980-2020-02418)

PLEXITRON SOLUTION ADMINISTRATION SETS Adverse Event — Malfunction (MDR 1416980-2020-02418) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PLEXITRON SOLUTION ADMINISTRATION SETS; Generic name: SET, ADMINISTRATION, INTRAVASCULAR; Manufacturer: BAXTER HEALTHCARE CORPORATION.

DevicePLEXITRON SOLUTION ADMINISTRATION SETS
Generic nameSET, ADMINISTRATION, INTRAVASCULAR
ManufacturerBAXTER HEALTHCARE CORPORATION
Report number1416980-2020-02418
Event typeMalfunction
Product problemY
Date received2020-04-28
Report sourceCOMPANY REPRESENTATIVE, FOREIG
NarrativeTHE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. A REVIEW OF THE IMAGE WAS PERFORMED AND DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THE REPORTED CONDITION WAS NOT VERIFIED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF TH
SourceopenFDA MAUDE (device adverse events)

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