MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-27 for MC3 CARDIOPULMONARY CRESCENT 28 FR DUAL LUMEN CATHETER 70128 manufactured by Mc3 Inc..
[177882538]
During procedure to cannulate right internal jugular vein for ecmo (using mc3 cardiopulmonary crescent 28 fr dual lumen catheter kit), as the last vein dilator was removed, approx 4 cm of the internal jugular vein was avulsed. Pt underwent immediate emergent surgical intervention to repair the vein. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092546 |
| MDR Report Key | 9636747 |
| Date Received | 2020-01-27 |
| Date of Report | 2020-01-23 |
| Date of Event | 2020-01-08 |
| Date Added to Maude | 2020-01-28 |
| 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 | RISK MANAGER |
| 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 | MC3 CARDIOPULMONARY CRESCENT 28 FR DUAL LUMEN CATHETER |
| Generic Name | DUAL LUMEN ECMO CANNULA |
| Product Code | PZS |
| Date Received | 2020-01-27 |
| Catalog Number | 70128 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MC3 INC. |
| Manufacturer Address | DEXTER MI 48130 US 48130 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2020-01-27 |