FDA Adverse Event
Malfunction
Summary report: N
DURASPAN DIALYSIS CATHETER 15.5F X 28CM
MDR report key: 1930011
·
Received November 19, 2010
Report
- Report Number
- 3006242715-2010-00005
- Event Type
- Malfunction
- Date Received
- November 19, 2010
- Date of Event
- November 10, 2010
- Report Date
- November 17, 2010
- Manufacturer
- R4 VASCULAR
- Product Code
- MSD
- PMA / PMN Number
- K100169
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INITIAL INSPECTION OF DEVICE AND UPON RETURN TO MANUFACTURER DID NOT DEMONSTRATE ANY SPECIFIC FAILURE CAUSE. THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. ADDITIONAL EVALUATION OF THE LOT IS IN PROCESS.
Description of Event or Problem · 1
LUERS CAME OFF OF THE CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURASPAN DIALYSIS CATHETER 15.5F X 28CM | DIALYSIS CATHETER | MSD | R4 VASCULAR | NA | R402D168P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |