PLEXOLONG NANOLINE® NRFIT®
Report
- Report Number
- 9611612-2024-00022
- Event Type
- Malfunction
- Date Received
- September 18, 2024
- Date of Event
- September 15, 2024
- Report Date
- November 8, 2024
- Manufacturer
- PAJUNK GMBH MEDIZINTECHNOLOGIE
- Product Code
- CAZ
- UDI-DI
- 04048223067451
- PMA / PMN Number
- K113188
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
EVENT TOOK PLACE IN FRANCE. BASED ON CLINICAL ASSESSMENT AND RISK ASSESSMENT THIS REPORT IS CONSIDERED AS CLOSED. IN CASE NEW INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SENT TO THE AGENCY.
EVENT TOOK PLACE IN FRANCE. THE PRODUCT ANALYSIS HAS BEEN IN PROGRESS SINCE THE INITIAL NOTICE DATED 09/18/2024. AND WILL BE PUBLISHED WITH THE TEST RESULTS IN THE FOLLOW-UP REPORT.
EVENT TOOK PLACE IN FRANCE. CORRECTION 08/11/2024: MANUFACTURING DATE CHANGE TO 06/20/2023. BASED ON CLINICAL ASSESSMENT AND RISK ASSESSMENT THIS REPORT IS CONSIDERED AS CLOSED. IN CASE NEW INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SENT TO THE AGENCY.
IRN# (B)(4). EVENT TOOK PLACE IN FRANCE. CATHETER ADAPTER APPEARS TO CRUSH THE CATHETER, MAKING INJECTION IMPOSSIBLE.
IRN# (B)(4). CATHETER ADAPTER APPEARS TO CRUSH THE CATHETER, MAKING INJECTION IMPOSSIBLE.
IRN# (B)(4). EVENT TOOK PLACE IN FRANCE. CATHETER ADAPTER APPEARS TO CRUSH THE CATHETER, MAKING INJECTION IMPOSSIBLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1360125 | PLEXOLONG NANOLINE® NRFIT® | PLEXOLONG NANOLINE® NRFIT®_ANAESTHESIA CONDUCTION KIT | CAZ | PAJUNK GMBH MEDIZINTECHNOLOGIE | 521166-31A | 1496 | 04048223067451 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other| R |