MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-07-23 for MEDISYSTEMS AV FISTULA NEEDLE D9-2005MG * manufactured by Medisystem Corp.
[321477]
When pt was cannulated and connected to their hip the venous needle made a (pop) sound and a blood stream expressed from the needle. Lines were clamped, blood catheter were drawn. The lifeline needle was pulled and pt was recannulated, and connected to treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1029101 |
| MDR Report Key | 474029 |
| Date Received | 2003-07-23 |
| Date Added to Maude | 2003-07-29 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDISYSTEMS AV FISTULA NEEDLE |
| Generic Name | FISTULA NEEDLE |
| Product Code | FEI |
| Date Received | 2003-07-23 |
| Model Number | D9-2005MG |
| Catalog Number | * |
| Lot Number | 2612F1 |
| ID Number | * |
| Device Expiration Date | 2005-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 462882 |
| Manufacturer | MEDISYSTEM CORP |
| Manufacturer Address | * SEATTLE WA 981013016 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-07-23 |