FDA Adverse Event
Malfunction
Summary report: N
DECATHLON DIALYSIS CATHETER
MDR report key: 1526406
·
Received November 5, 2009
Report
- Report Number
- 1526406
- Event Type
- Malfunction
- Date Received
- November 5, 2009
- Date of Event
- August 14, 2009
- Report Date
- November 4, 2009
- Manufacturer
- SPIRE BIOMEDICAL INC.
- Product Code
- MSD
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- ME, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
RECEIVED CALL ABOUT THE CATHETER REPLACEMENTS DONE BY VASCULAR PROVIDER. CATHETERS BEING USED ARE NOT HOLDING UP, AND SHOULD LAST A YEAR OR TWO. THESE ARE NOT LASTING SIX WEEKS ON THIS PATIENT. ALSO OTHER PATIENTS CATHETERS ARE SHOWING STRESS CRACKS. HE IS MOSTLY CONCERNED ABOUT PRODUCT BEING USED AND THE PATIENT HAVING TO UNDERGO ANOTHER SURGICAL PROCEDURE.
Description of Event or Problem · 1
RECEIVED CALL ABOUT THE CATHETER REPLACEMENTS DONE BY VASCULAR PROVIDER. CATHETERS BEING USED ARE NOT HOLDING UP, AND SHOULD LAST A YEAR OR TWO. THESE ARE NOT LASTING SIX WEEKS ON THIS PATIENT. ALSO OTHER PATIENTS CATHETERS ARE SHOWING STRESS CRACKS. HE IS MOSTLY CONCERNED ABOUT PRODUCT BEING USED AND THE PATIENT HAVING TO UNDERGO ANOTHER SURGICAL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DECATHLON DIALYSIS CATHETER | HEMODIALYSIS CATHETER | MSD | SPIRE BIOMEDICAL INC. | * | 99607981 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR |