MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-10-14 for BARD NIAGARA 20 CM STRAIGHT CATHETER * manufactured by Bard Access Systems.
[116542]
10/9/98 while attempting to initiate dialysis with 20 cm niagara dialysis catheter (bard) when aspirating from venous lumen, "air" heard. Treatment started - blood oozing but from venous hub. Treatment stopped. All blood returned via arterial lumen. Catheter out 2 inches when surgeon arrived. Rt catheter removed without problems. 20 cm niagara placed on lt femoral area.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 191646 |
| MDR Report Key | 191646 |
| Date Received | 1998-10-14 |
| Date of Report | 1998-10-09 |
| Date of Event | 1998-10-09 |
| Date Facility Aware | 1998-10-09 |
| Report Date | 1998-10-09 |
| Date Reported to FDA | 1998-10-11 |
| Date Added to Maude | 1998-10-16 |
| 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 |
| 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 | BARD NIAGARA 20 CM STRAIGHT CATHETER |
| Generic Name | HEMODIALYSIS CATHETER |
| Product Code | LFK |
| Date Received | 1998-10-14 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 186224 |
| Manufacturer | BARD ACCESS SYSTEMS |
| Manufacturer Address | 5425 W. AMELIA EARHART DR SALT LAKE CITY UT 84116 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-10-14 |