FDA Adverse Event
Injury
Summary report: N
NAVILYST / VAXCEL
MDR report key: 2032665
·
Received March 17, 2011
Report
- Report Number
- 1317056-2011-00026
- Event Type
- Injury
- Date Received
- March 17, 2011
- Date of Event
- February 24, 2011
- Report Date
- February 25, 2011
- Manufacturer
- NAVILYST MEDICAL
- Product Code
- LJT
- PMA / PMN Number
- K942623
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION INTO THIS EVENT, INCLUDING THE DEVICE EVALUATION, IS STILL ON-GOING. AT THE COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
AS REPORTED, DURING A PROCEDURE TO REMOVE AN 8F VALVED PORT, THE CATHETER FRACTURED AND DETACHED. THE PORT HAD BEEN IMPLANTED SINCE (B)(6) 2009. ON (B)(6), 2011, THE REMAINDER OF THE CATHETER WAS REMOVED. NO PATIENT COMPLICATIONS OCCURRED. THE PORT HAS BEEN RETURNED TO NAVILYST MEDICAL, HOWEVER, THE CATHETER WAS DISCARDED WHEN IT WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NAVILYST / VAXCEL | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS | LJT | NAVILYST MEDICAL | NA | 1295864 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |