FDA Adverse Event
Malfunction
Summary report: N
BIOFLEX TESIO CATH
MDR report key: 1022049
·
Received March 28, 2008
Report
- Report Number
- 2518902-2008-00010
- Event Type
- Malfunction
- Date Received
- March 28, 2008
- Date of Event
- January 8, 2008
- Report Date
- March 26, 2008
- Manufacturer
- MEDCOMP
- Product Code
- MSD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION HAS BEEN INITIATED. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT ALL DEVICE SPECIFICATIONS AND QUALITY REQUIREMENTS WERE SATISFIED. THE DEVICE SAMPLE WAS FORWARDED TO THE MFR FOR EVAL. WHEN THE INVESTIGATION IS COMPLETE, A FINAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A TEAR IN THE LUMEN SECTION THAT IS OVER THE METAL CANNULA AND UNDER THE COMPRESSION RING AND COLLAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOFLEX TESIO CATH | HEMODIALYSIS CATHETER | MSD | MEDCOMP | BFS-6-J | MALA500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Required Intervention |