FDA Adverse Event
Malfunction
Summary report: N
PORT ACCESS NEEDLE
MDR report key: 19151795
·
Received April 22, 2024
Report
- Report Number
- 19151795
- Event Type
- Malfunction
- Date Received
- April 22, 2024
- Date of Event
- January 26, 2024
- Report Date
- April 5, 2024
- Manufacturer
- BARD ACCESS SYSTEMS, INC.
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PATIENT UNDERWENT FLURO AND CONTRAST INJECTION FOR EVALUATION OFF EXISTING CVAD (CENTRAL VENOUS ACCESS DEVICE). AFTER PROCEDURE, NEEDLE COVER/PROTECTION DEVICE DID NOT DEPLOY TO COVER NEEDLE WHEN REMOVING PORT NEEDLE. MANUFACTURER RESPONSE FOR POWER INJECTABLE INFUSION SET, POWER LOC MAX NEEDLE (PER SITE REPORTER). EQUIPMENT FAILURE REPORTED TO BD CUSTOMER SERVICE (844-823-5433). REPRESENTATIVE INDICATED SOMEONE WOULD BE IN TOUCH WITH ME VIA EMAIL AND WILL PROVIDE MAILING LABELS. EQUIPMENT IS AVAILABLE FOR RETURN TO THE MANUFACTURER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2587310 | PORT ACCESS NEEDLE | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BARD ACCESS SYSTEMS, INC. | 0132075 | ASGYFC060 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Male |