FDA Adverse Event
Injury
Summary report: N
HEMOSPLIT, 14.5 FR, STANDARD KIT, 19 CM, STRAIGH
MDR report key: 2896425
·
Received December 28, 2012
Report
- Report Number
- 3006260740-2012-00481
- Event Type
- Injury
- Date Received
- December 28, 2012
- Date of Event
- September 8, 2012
- Report Date
- December 7, 2012
- Manufacturer
- C. R. BARD INC. (BASD)
- Product Code
- MSD
- PMA / PMN Number
- K030020
- Adverse Event
- 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) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.
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. FROM THAT TIME TO (B)(6) 2012, HEMODIALYSIS IS SUCCESSFUL. (B)(6) 2012. THE DOCTOR FOUND THE PATIENT'S CATHETER OUT OF POSITION 3CM WHEN HE WAS STAYED AT HOME. THE DOCTOR CHECKED AND CONFIRMED THAT THE CUFF WAS STILL IN PATIENT'S BODY. THE CATHETER SEPARATED FROM THE CUFF. THE DOCTOR HAS TO CHANGE A NEW CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEMOSPLIT, 14.5 FR, STANDARD KIT, 19 CM, STRAIGH | MSD | C. R. BARD INC. (BASD) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |