FDA Adverse Event
Malfunction
Summary report: N
DIALYSIS IMPLANTED CATHETER
MDR report key: 1900332
·
Received October 26, 2010
Report
- Report Number
- 3006260740-2010-00303
- Event Type
- Malfunction
- Date Received
- October 26, 2010
- Date of Event
- May 27, 2010
- Report Date
- October 14, 2010
- Manufacturer
- C. R. BARD INC. (BASD)
- Product Code
- MSD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A CHR REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.
Description of Event or Problem · 1
FACILITY REPORTS THEY HAVE HAD A NUMBER OF EVENTS OF BREAKAGE IN THE BIFURCATION OF BOTH HEMOGLIDE AND HEMOSTAR CATHETERS. THEY HAVE NOT SAVED ANY EXPLANTED CATHETERS. WE HAVE REQUESTED FOR MORE INFO AND ANY ADDITIONAL INFO WILL BE ADDED LATER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DIALYSIS IMPLANTED CATHETER | CATHETER, HEMODIALYSIS, IMPLANTED | MSD | C. R. BARD INC. (BASD) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |