FDA Adverse Event
Injury
Summary report: N
CELSITE ACCESS PORT
MDR report key: 3879478
·
Received May 28, 2014
Report
- Report Number
- 9612452-2014-00011
- Event Type
- Injury
- Date Received
- May 28, 2014
- Report Date
- May 28, 2014
- Manufacturer
- B. BRAUN MEDICAL SAS
- Product Code
- LJT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION: DESPITE OUR REQUESTS, NO INFORMATION HAVE BEEN FORWARDED TO THE MANUFACTURER. WITHOUT THE DEVICE, NOR THE BATCH NUMBER, NOR INFORMATION ABOUT THE IMPLANTATION PROCEDURE, NO THOROUGH INVESTIGATION CAN BE PERFORMED. NO CONCLUSION CAN BE DRAWN. IT IS WORTH NOTING THAT THE CELSITE ST501 ACCESS PORT, REFERENCE 4437022 IS NOT CLEARED IN THE US, BUT THIS DEVICE IS SIMILAR TO THE REFERENCE 05437025 (K130576).
Description of Event or Problem · 1
ACCESS PORT ASCENTS TO THE SURFACE OF THE SKIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 314172 | CELSITE ACCESS PORT | ACCESS PORT SYSTEM | LJT | B. BRAUN MEDICAL SAS | ST501 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |