FDA Adverse Event
Injury
Summary report: N
CELSITE ACCESS PORT
MDR report key: 3717199
·
Received March 21, 2014
Report
- Report Number
- 9612452-2014-00008
- Event Type
- Injury
- Date Received
- March 21, 2014
- Report Date
- March 19, 2014
- Manufacturer
- B. BRAUN MEDICAL SAS
- Product Code
- LJT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
BATCH HISTORY REVIEW: NO OTHER SIMILAR INCIDENTS WERE DECLARED TO US CONCERNING THIS BATCH OF ACCESS PORTS. INVESTIGATION: NO DEVICE RETURNED FOR EVALUATION. CONCLUSION: OUR COMPLAINT HANDLING DATABASE DOES NOT SHOW ANY INCREASING TREND FOR THIS TYPE OF COMPLAINT. IT IS AN ISOLATED CASE. NO CORRECTIVE ACTION IS ENVISAGED. IT IS WORTH NOTHING THAT THE CELSITE T305 ACCESS PORT, REFERENCE (B)(4) IS NOT CLEARED IN THE US, BUT THIS DEVICE IS SIMILAR TO THE REFERENCE (B)(4) (K130576).
Description of Event or Problem · 1
ALLERGIC REACTION AROUND THE ACCESS PORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 168856 | CELSITE ACCESS PORT | ACCESS PORT SYSTEM | LJT | B. BRAUN MEDICAL SAS | ST301F | M0436890 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |