FDA Adverse Event
Malfunction
Summary report: N
AP204 - MICROBORE WITH NON-VENTED SPIKE, 0.2 MICRON FILTER AND BACK CHECK VALVE
MDR report key: 13423013
·
Received February 2, 2022
Report
- Report Number
- 3010293992-2022-00002
- Event Type
- Malfunction
- Date Received
- February 2, 2022
- Date of Event
- January 14, 2022
- Report Date
- April 4, 2022
- Manufacturer
- EITAN MEDICAL LTD
- Product Code
- FPA
- PMA / PMN Number
- K141834
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
EITAN MEDICAL LTD IS FORMERLY NAMED Q CORE MEDICAL LTD. THE FEI NUMBER IS THE SAME (B)(4).
Additional Manufacturer Narrative · 0
EITAN MEDICAL LTD IS FORMERLY NAMED Q CORE MEDICAL LTD. THE FEI NUMBER IS THE SAME 3010293992.
Description of Event or Problem · 0
THE COMPLAINT WAS REPORTED BY A CUSTOMER FROM USA: LEAKAGE ISSUE.
Description of Event or Problem · 0
THE COMPLAINT WAS REPORTED BY A CUSTOMER FROM USA: LEAKAGE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 84783 | AP204 - MICROBORE WITH NON-VENTED SPIKE, 0.2 MICRON FILTER AND BACK CHECK VALVE | ADMINISTRATION SET | FPA | EITAN MEDICAL LTD | 0187.2309.11 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |