MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-08-26 for BARD * 0603590 manufactured by Bard Acess Systems.
[21616038]
In 7/26/2004 pt had groshong/mri port insertion for breast cancer-chest x-ray showed tip in right atrium. Pt returned to surgery after one month because of port malfunction. Catheter was removed, and it was noted that there was a fracture of catheter at the level where the catheter passed over the clavicle with migration of the catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1033092 |
| MDR Report Key | 554395 |
| Date Received | 2004-08-26 |
| Date of Report | 2004-08-25 |
| Date of Event | 2004-08-16 |
| Date Added to Maude | 2004-11-15 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD |
| Generic Name | GROSHONG CATHETER 8 FR. |
| Product Code | DQD |
| Date Received | 2004-08-26 |
| Model Number | * |
| Catalog Number | 0603590 |
| Lot Number | 22E04518 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 544023 |
| Manufacturer | BARD ACESS SYSTEMS |
| Manufacturer Address | 5245 W. AMELIA EARHART SALT LAKE CITY UT * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-08-26 |