FDA Adverse Event
Malfunction
Summary report: N
HICKMAN HEMODIALYSIS/APHERESIS 13.5 FR ROUND DUAL-LUMEN CA
MDR report key: 2043125
·
Received February 24, 2011
Report
- Report Number
- 3006260740-2011-00052
- Event Type
- Malfunction
- Date Received
- February 24, 2011
- Date of Event
- August 25, 2010
- Report Date
- February 16, 2011
- Manufacturer
- C. R. BARD INC. (BASD)
- Product Code
- LJS
- PMA / PMN Number
- K830233
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A CHR OF LOT #RETA0056 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.
Description of Event or Problem · 1
THE CATHETER WAS IMPLANTED BY THE IR SERVICE. THE DAY AFTER THEY WERE INFORMED THAT THE ARTERIAL ROUTE HAD A LEAKAGE (WHEN CLAMP WAS CLOSED AND A SOLUTION WAS INJECTED IT WAS DETECTED THAT THE CATHETER HAD A SMALL HOLE). THE CATHETER WAS REMOVED AFTER FEW DAYS. NO DAMAGES FOR THE PATIENT. THE USED TECHNIQUE WAS SELDINGER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HICKMAN HEMODIALYSIS/APHERESIS 13.5 FR ROUND DUAL-LUMEN CA | LJS | C. R. BARD INC. (BASD) | RETA0056 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |