FDA Adverse Event
Injury
Summary report: N
ROCKET IPC PLEURAL CATHETER
MDR report key: 9249992
·
Received October 28, 2019
Report
- Report Number
- MW5090746
- Event Type
- Injury
- Date Received
- October 28, 2019
- Date of Event
- October 16, 2019
- Report Date
- October 21, 2019
- Manufacturer
- ROCKET MEDICAL PLC
- Product Code
- DWM
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- DE, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
UPON REMOVAL OF THE PLEURAL CATHETER, THE CATHETER FRACTURED LEAVING PART OF IT IN THE PLEURAL SPACE. AN INCISION WAS REQUIRED TO RETRIEVE AND REMOVE THE REMAINING PORTION OF THE CATHETER FROM THE PLEURAL SPACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1042063 | ROCKET IPC PLEURAL CATHETER | APPARATUS, SUCTION, PATIENT CARE | DWM | ROCKET MEDICAL PLC | R51400-16-PL | 477903 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Other| R |