MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-30 for EDWARDS OXIMETRY CVC VANTEX X3816KT manufactured by Edwards Lifesciences Llc.
[146497623]
This was a double lumen central line kit. Patient was status post open heart surgery. Had just returned from or when attempting to draw back blood, air was noted in the cvc lumen. Md notified and cvc discontinued. On removal of cvc and inspection of device, a small leak just below the hub was noticed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8653355 |
| MDR Report Key | 8653355 |
| Date Received | 2019-05-30 |
| Date of Report | 2019-05-22 |
| Date of Event | 2019-04-24 |
| Report Date | 2019-05-22 |
| Date Reported to FDA | 2019-05-22 |
| Date Reported to Mfgr | 2019-05-30 |
| Date Added to Maude | 2019-05-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | EDWARDS OXIMETRY CVC VANTEX |
| Generic Name | CATHETER, OXIMETER, FIBEROPTIC |
| Product Code | DQE |
| Date Received | 2019-05-30 |
| Model Number | X3816KT |
| Catalog Number | X3816KT |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES LLC |
| Manufacturer Address | ONE EDWARDS WAY IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-30 |