FDA Adverse Event
Malfunction
Summary report: N
CADD® CADD® EXTENSION SETS
MDR report key: 8186577
·
Received December 20, 2018
Report
- Report Number
- 3012307300-2018-08904
- Event Type
- Malfunction
- Date Received
- December 20, 2018
- Report Date
- December 20, 2018
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- FPA
- UDI-DI
- 10610586023279
- PMA / PMN Number
- K974013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
INFORMATION WAS RECEIVED INDICATING THAT THE EXTENSION SET EXHIBITED LEAKING AT THE CONNECTION OF CADD EXTENSION TUBING AND ULTRASITE CAP. PATIENT REPORTED THAT SHE EXPERIENCED LIGHTHEADEDNESS. THERE WERE NO LONG TERM PATIENT ADVERSE EFFECTS DUE TO THE REPORTED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1024623 | CADD® CADD® EXTENSION SETS | SET, ADMINISTRATION, INTRAVASCULAR | FPA | SMITHS MEDICAL ASD, INC. | 10610586023279 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR |