MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-10 for GROSHONG CV CATHETER manufactured by C.r. Bard, Inc..
[13239]
Had initial groshong catheter (single lumen) inserted 10/10/94. Removed in physician office 11/28/94 and scheduled for replacement 12/1/94. After placing second groshong, chest x-ray revealed evidence of a portion or tip of old groshong catheter in region of right ventricle. Required removal under fluoroscopic guidance venous access.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 25467 |
| MDR Report Key | 25467 |
| Date Received | 1995-01-10 |
| Date of Report | 1994-12-08 |
| Date of Event | 1994-11-28 |
| Date Facility Aware | 1994-12-02 |
| Report Date | 1994-12-08 |
| Date Reported to Mfgr | 1994-12-08 |
| Date Added to Maude | 1995-09-14 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GROSHONG CV CATHETER |
| Generic Name | CENTRAL VENOUS CATHETER |
| Product Code | LLX |
| Date Received | 1995-01-10 |
| Lot Number | 36EE0489 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 25965 |
| Manufacturer | C.R. BARD, INC. |
| Manufacturer Address | 5425 W. AMELIA EARHART DRIVE SALT LAKE CITY UT 84116 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-01-10 |