FDA Adverse Event
Malfunction
Summary report: N
HEMOSPLIT, 14.5 FR, STANDARD KIT, 19 CM, CURVED
MDR report key: 2860045
·
Received December 4, 2012
Report
- Report Number
- 3006260740-2012-00444
- Event Type
- Malfunction
- Date Received
- December 4, 2012
- Date of Event
- October 26, 2012
- Report Date
- November 15, 2012
- Manufacturer
- C. R. BARD INC. (BASD)
- Product Code
- MSD
- PMA / PMN Number
- K030020
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION, AS THE DEVICE WAS DISCARDED AFTER THE EVENT OCCURRED. A LOT HISTORY REVIEW (LHR) OF REVF1240 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DOCTOR IMPLANTED A LONG TERM CATHETER FROM RIGHT INTERNAL JUGULAR IN (B)(6) 2012. SUCCESSFUL HEMODIALYSIS 3 MONTH. ON (B)(6) 2012 THE PATIENT'S CATHETER WAS OUT OF THE BODY 4 CM WHEN HE HEMODIALYSIS AT HOSPITAL. THE DOCTOR FOUND THE CUFF STILL IN PATIENT'S BODY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEMOSPLIT, 14.5 FR, STANDARD KIT, 19 CM, CURVED | MSD | C. R. BARD INC. (BASD) | REVF1240 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |