FDA Adverse Event
Injury
Summary report: N
EPILONG CATH 20GX90CM
MDR report key: 22436794
·
Received July 8, 2025
Report
- Report Number
- 9611612-2025-00031
- Event Type
- Injury
- Date Received
- July 8, 2025
- Date of Event
- August 24, 2023
- Report Date
- July 8, 2025
- Manufacturer
- PAJUNK GMBH MEDIZINTECHNOLOGIE
- Product Code
- BSO
- UDI-DI
- 04048223052488
- PMA / PMN Number
- K060311
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS CASE IS REPORTED IN RETROSPECT BASED ON A RE-EVALUATION CONDUCTED IN 2025 FOR FORMAL REASONS. THERE WAS NO PARTICULAR RISK TO PATIENTS, USERS, OR THIRD PARTIES.
Description of Event or Problem · 0
IRN# (B)(6). INCIDENT OCCURRED IN ITALY. DURING THE PROCEDURE TO REMOVE THE EPIDURAL CATHETER DURING BIRTH DELIVERY EPIDURAL PROCEDURE, WE NOTICED THAT THE CATHETER WAS BROKEN AT HALF LENGHT. WE REMOVED BOTH PARTES OF THE CATHETER AND WE MADE A MEDICATION IN THE ENTRY POINT OF THE CATHETER ON THE SKIN. NO OTHER ANOMALIES WERE NOTICED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 388559 | EPILONG CATH 20GX90CM | EPILONG CATH 20GX90CM | BSO | PAJUNK GMBH MEDIZINTECHNOLOGIE | 1473 | 04048223052488 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |