FDA Adverse Event
Malfunction
Summary report: N
POWER PORT PORTACATH
MDR report key: 8382044
·
Received February 28, 2019
Report
- Report Number
- MW5084547
- Event Type
- Malfunction
- Date Received
- February 28, 2019
- Date of Event
- February 26, 2019
- Report Date
- February 26, 2019
- Manufacturer
- BARD ACCESS SYSTEMS
- Product Code
- LJT
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
BARD ACCESS SYSTEMS, POWER PORT, PORTACATH, WOULD NOT ALLOW A BLOOD RETURN UPON IMPLANTATION. THIS DEVICE WAS REMOVED AND REPLACED WITH A ¿LIKE¿ DEVICE THAT THEN FUNCTIONED WITHOUT ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 170296 | POWER PORT PORTACATH | PORT CATHETER IMPLANTED SUBCUTANEOUS INTRAVASCULAR | LJT | BARD ACCESS SYSTEMS | 1808000 | RECX1821 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR |