FDA Adverse Event
Injury
Summary report: N
IMPLANTED HICKMAN CATHETER
MDR report key: 1779178
·
Received July 29, 2010
Report
- Report Number
- 3006260740-2010-00224
- Event Type
- Injury
- Date Received
- July 29, 2010
- Report Date
- July 29, 2010
- Manufacturer
- C. R. BARD INC. (BASD)
- Product Code
- LJT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
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
COMPANY EMPLOYEE PROVIDED A PAGE FROM AN ARTICLE IN "ENDOVASCULAR TODAY" (JULY 2010, P 31). IN FIGURE 3, THE DESCRIPTION STATES: "IN THIS PT, A LONG SECTION OF HICKMAN CATHETER (BARD PERIPHERAL VASCULAR, INC. (B)(4)) TUBING WAS RETAINED WHEN THE CATHETER FRACTURED DURING REMOVAL. AS ONE END WAS EMBEDDED IN A CATHETER WAS PASSED BEHIND THE HICKMAN TUBING ....ONCE THE CAPTURE WAS COMPLETE, THE ASSEMBLY WAS WITHDRAWN."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMPLANTED HICKMAN CATHETER | UNK | LJT | C. R. BARD INC. (BASD) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |