MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-14 for MEDTRONIC DLP 24 FR METAL RIGHT ANGLE VENOUS CANNULA 24FR SINGLE STAGE VENOUS CANNULA 69324 manufactured by Medtronic, Inc..
[180043415]
Upon decannulation of the ivc, it was noted that the 24 fr right angle cannula used contained clot. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093030 |
| MDR Report Key | 9720839 |
| Date Received | 2020-02-14 |
| Date of Report | 2020-02-12 |
| Date of Event | 2020-02-10 |
| Date Added to Maude | 2020-02-18 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | MEDTRONIC DLP 24 FR METAL RIGHT ANGLE VENOUS CANNULA |
| Generic Name | CATHETER, CANNULA AND TUBING VASCULAR, CARDIOPULMONARY BYPASS |
| Product Code | DWF |
| Date Received | 2020-02-14 |
| Model Number | 24FR SINGLE STAGE VENOUS CANNULA |
| Catalog Number | 69324 |
| Lot Number | 2019110840 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC, INC. |
| Manufacturer Address | MINNEAPOLIS MN 55432 US 55432 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-14 |