FDA Adverse Event
Injury
Summary report: N
CELSITE ACCESS PORT
MDR report key: 5052712
·
Received September 1, 2015
Report
- Report Number
- 9612452-2015-00018
- Event Type
- Injury
- Date Received
- September 1, 2015
- Date of Event
- June 12, 2015
- Report Date
- August 26, 2015
- Manufacturer
- B. BRAUN MEDICAL SAS
- Product Code
- LJT
- PMA / PMN Number
- K130576
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
BATCH HISTORY REVIEW: THE MANUFACTURING FILE WAS REVIEWED. IT IS COMPLIANT WITH OUR SPECIFICATIONS AND NO ABNORMALITY WAS DETECTED. ANOTHER COMPLAINT FROM THE SAME HEALTH FACILITY WAS REPORTED TO US ON THIS BATCH OF ACCESS PORTS. INVESTIGATION: DESPITE SEVERAL REQUESTS, THE DEVICE NOR THE X-RAY PICTURES HAVE BEEN FORWARDED TO THE MANUFACTURER. WITHOUT THESE ELEMENTS, NO THOROUGH INVESTIGATION CAN BE PERFORMED. NO CONCLUSION CAN BE DRAWN.
Description of Event or Problem · 1
"THE PATIENT RECEIVED HER TREATMENT AT DAY HOSPITAL. DURING THE INJECTION, SHE COMPLAINED OF PAINS. THE PATIENT WAS PUNCTURED AGAIN AND SENT FOR X-RAY CHECK. THE CATHETER WAS DISCONNECTED FROM THE ACCESS PORT. THE PATIENT WAS SENT TO THE CH OF AVIGNON FOR CATHETER REMOVAL."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 579662 | CELSITE ACCESS PORT | ACCESS PORT SYSTEM | LJT | B. BRAUN MEDICAL SAS | NA | 36895403 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |