FDA Adverse Event
Malfunction
Summary report: N
AP210 - MICROBORE WITH NON-VENTED SPIKE AND 1.2UM FILTER
MDR report key: 19546984
·
Received June 17, 2024
Report
- Report Number
- 3010293992-2024-00032
- Event Type
- Malfunction
- Date Received
- June 17, 2024
- Report Date
- April 10, 2025
- Manufacturer
- EITAN MEDICAL LTD.
- Product Code
- FPA
- PMA / PMN Number
- K141834
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THIS REPORTED EVENT OCCURRED OUTSIDE OF THE US ON A DEVICE THAT IS SIMILAR TO THE ONE MARKETED IN THE US AND FOR WHICH THERE IS NO DATA IN GUDID. DEVICE'S PREMARKET SUBMISSION NUMBER: K141834.
Description of Event or Problem · 0
THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM THE UK. LEAKAGE ISSUE.
Description of Event or Problem · 0
THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM THE UK. LEAKAGE ISSUE.
Description of Event or Problem · 0
THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM THE UK. LEAKAGE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2323645 | AP210 - MICROBORE WITH NON-VENTED SPIKE AND 1.2UM FILTER | ADMINISTRATION SET | FPA | EITAN MEDICAL LTD. | 0852.0606.23 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |