FDA Adverse Event
Malfunction
Summary report: N
HICKMAN 7 FR DUAL-LUMEN CV CATHETER, CUTDOWN TRAY WITH SURE
MDR report key: 2062495
·
Received March 18, 2011
Report
- Report Number
- 3006260740-2011-00080
- Event Type
- Malfunction
- Date Received
- March 18, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 9, 2011
- Manufacturer
- C.R. BARD, INC. (BASD)
- Product Code
- LJS
- PMA / PMN Number
- K830233
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A CHR OF LOT # HUUF1748 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FOR THIS LOT NUMBER.
Description of Event or Problem · 1
IT WAS REPORTED THAT IT WAS DIFFICULT TO FLUSH THE CATHETER. DURING X-RAY, IT WAS NOTICED THAT CONTRAST MEDIUM LEAK BETWEEN THE CUFF AND THE VEIN. THEREUPON THE CATHETER WAS EXPLANTED. THE EXPLANTED CATHETER SHOWED CRACKS IN THE AREA BETWEEN THE HUB AND THE TIP OF THE CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HICKMAN 7 FR DUAL-LUMEN CV CATHETER, CUTDOWN TRAY WITH SURE | LJS | C.R. BARD, INC. (BASD) | HUUF1748 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2 YR | Required Intervention |