FDA Adverse Event
Injury
Summary report: N
EPILONG II
MDR report key: 23109511
·
Received September 22, 2025
Report
- Report Number
- 9611612-2025-00042
- Event Type
- Injury
- Date Received
- September 22, 2025
- Date of Event
- July 29, 2025
- Report Date
- October 31, 2025
- Manufacturer
- PAJUNK GMBH MEDIZINTECHNOLOGIE
- Product Code
- CAZ
- PMA / PMN Number
- K060311
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
IRN# (B)(4). INCIDENT OCCURRED IN ITALY. THIS CASE IS CONSIDERED AS CLOSED. IF FURTHER INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SENT TO THE AGENCY.
Additional Manufacturer Narrative · 0
IRN#(B)(4). INCIDENT OCCURRED IN ITALY. THE FINAL RESULTS WILL BE SENT TO AGENCY AFTER INVESTIGATION OF AFFECTED DEVICE.
Description of Event or Problem · 0
IRN# (B)(4). INCIDENT OCCURRED IN ITALY. UPON COMPLETION OF THE PROCEDURE, DURING CATHETER WITHDRAWAL, THE DISTAL TIP OF THE CATHETER WAS RETAINED WITHIN THE PATIENT.
Description of Event or Problem · 0
IRN#(B)(4). INCIDENT OCCURRED IN ITALY. UPON COMPLETION OF THE PROCEDURE, DURING CATHETER WITHDRAWAL, THE DISTAL TIP OF THE CATHETER WAS RETAINED WITHIN THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2701408 | EPILONG II | EPILONG II TUOHY II 18G X 90MM | CAZ | PAJUNK GMBH MEDIZINTECHNOLOGIE | 1556 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |