FDA Adverse Event
Malfunction
Summary report: N
NEUTRACLEAR NEEDLE-FREE VALVE
MDR report key: 9461598
·
Received December 12, 2019
Report
- Report Number
- 9616066-2019-03657
- Event Type
- Malfunction
- Date Received
- December 12, 2019
- Report Date
- December 2, 2019
- Manufacturer
- CAIR LGL
- Product Code
- FPA
- PMA / PMN Number
- K171117
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION PROVIDED IN B.5, & D.4.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE NEUTRACLEAR AND PRIMARY TUBING WERE "STUCK". ALTHOUGH REQUESTED, THERE HAS BEEN NO FURTHER PATIENT OR EVENT INFORMATION MADE AVAILABLE TO DATE.
Additional Manufacturer Narrative · 1
UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED COMPLAINT BECAUSE THE SET HAS BEEN DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED. PATIENT WAS A INFANT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE NEUTRACLEAR AND PRIMARY TUBING WAS "STUCK".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1256845 | NEUTRACLEAR NEEDLE-FREE VALVE | SET, ADMINISTRATION, INTRAVASCULAR | FPA | CAIR LGL | EL-NC1001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | PRIMARY TUBING, THERAPY DATE UNKNOWN. |