D
Patient 1
BLUE LUER CAME OFF OF THE CATHETER.
MAUDE MDR 1864406
- MDR report key
- 1864406
- Report number
- 3006242715-2010-00002
- Event key
- 0
- Event type
- 3
- Date of event
- 2010-09-17
- Date received
- 2010-10-04
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- LAURIE LEWANDOWSKI
- Address
- 7550 MERIDIAN CIRCLE N STE 150 MAPLE GROVE MN 55369 US
- Phone
- 866-866-8669
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | DURASPAN DIALYSIS CATHETER 15.5F X 28CM | DIALYSIS CATHETER | R4 VASCULAR | MSD | 62152820 | R403D140P | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2010-10-04 | 0 | 1. R |
Event Narratives#
N
Patient 1
INITIAL INSPECTION OF DEVICES AT THE CENTER DID NOT DEMONSTRATE ANY SPECIFIC FAILURE CAUSE. THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECS. ADD'L EVAL OF THE LOT IS IN PROCESS.