SOFT FLOW 6384

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-05 for SOFT FLOW 6384 manufactured by Mc3 Inc..

Event Text Entries

[177803804] At the end of a cabg procedure, the medtronic 6384 8. 0 mm aortic cannula was being removed and it fell apart.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9671091
MDR Report Key9671091
Date Received2020-02-05
Date of Report2019-12-16
Date of Event2019-12-12
Report Date2019-12-16
Date Reported to FDA2019-12-16
Date Reported to Mfgr2020-02-05
Date Added to Maude2020-02-05
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSOFT FLOW
Generic NameCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Product CodeDWF
Date Received2020-02-05
Model Number6384
Catalog Number6384
Lot Number1610105
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMC3 INC.
Manufacturer Address2555 BISHOP CIRCLE WEST DEXTER MI 48130 US 48130


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-05

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