FDA Adverse Event
Injury
Summary report: N
TURBO-JECT DOUBLE LUMEN MINOCYCLINE/RIFAMPIN BEDSIDE POWER-INJECTABLE PICC
MDR report key: 3232273
·
Received July 10, 2013
Report
- Report Number
- 1820334-2013-00273
- Event Type
- Injury
- Date Received
- July 10, 2013
- Report Date
- June 18, 2013
- Manufacturer
- COOK, INC.
- Product Code
- FOZ
- PMA / PMN Number
- K010034
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
PT AND DEVICE CODES: DEEP VEIN THROMBOSIS IS NOT LABELED IN THE IFU. EVENT EVALUATION: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
PT EXPERIENCED DEEP VEIN THROMBOSIS. PICC LINE WAS REMOVED AND REPLACED. NO ADDITIONAL INFO HAS BEEN PROVIDED BY THE REPORTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 317829 | TURBO-JECT DOUBLE LUMEN MINOCYCLINE/RIFAMPIN BEDSIDE POWER-INJECTABLE PICC | FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS | FOZ | COOK, INC. | NA | 3662952 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |