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..
[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
| Report Number | 9671091 |
| MDR Report Key | 9671091 |
| Date Received | 2020-02-05 |
| Date of Report | 2019-12-16 |
| Date of Event | 2019-12-12 |
| Report Date | 2019-12-16 |
| Date Reported to FDA | 2019-12-16 |
| Date Reported to Mfgr | 2020-02-05 |
| Date Added to Maude | 2020-02-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOFT FLOW |
| Generic Name | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS |
| Product Code | DWF |
| Date Received | 2020-02-05 |
| Model Number | 6384 |
| Catalog Number | 6384 |
| Lot Number | 1610105 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MC3 INC. |
| Manufacturer Address | 2555 BISHOP CIRCLE WEST DEXTER MI 48130 US 48130 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-05 |