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MINICAP TRANSFER SET Adverse Event — Malfunction (MDR 1416980-2020-02425)

MINICAP TRANSFER SET Adverse Event — Malfunction (MDR 1416980-2020-02425) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: MINICAP TRANSFER SET; Generic name: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE; Manufacturer: BAXTER HEALTHCARE CORPORATION.

DeviceMINICAP TRANSFER SET
Generic nameSET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
ManufacturerBAXTER HEALTHCARE CORPORATION
Report number1416980-2020-02425
Event typeMalfunction
Product problemY
Date received2020-04-28
Report sourceCOMPANY REPRESENTATIVE, FOREIG
NarrativeADDITIONAL INFORMATION: H3, H6. H10: ONE (1) ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED WITH THE NAKED EYE NOTED A BROKEN MAIN BODY. FUNCTIONAL TESTING INCLUDING LEAK, CLEAR PASSAGE, AND CLAMP FUNCTION TESTING WERE PERFORMED WITH NO ISSUES NOTED. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED. SHOULD ADDITIONAL REL
SourceopenFDA MAUDE (device adverse events)

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