MAUDE Adverse Event Report: B.BRAUN MEDICAL SAS CELSITE; ACCESS PORT SYSTEM

Model Number 4430425

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2017

Event Type  Injury  

Manufacturer Narrative

Product reference 4430425 is not cleared for sales in the usa, but it is similar to the product reference 5430425 cleared under #510k 130576.Batch history review: the manufacturing file was reviewed.The sterilisation file and the lab test results have been checked.They are compliant with the specifications and no abnormality was detected during production.No other complaint has been reported on this access port batch sold since january 2017.Investigation: the involved device was discarded and is not available for evaluation.Conclusion: without element, no conclusion can be drawn.However it is worth noting that several factors can contribute to this type of incident: too superficial implantation of the port, allergy to any of the materials used in the port, incision over the port septum, leakage of product from the port, particularly chemotherapy drugs, infection, radiation over the port site (leads to fragile skin),.It is an isolated case, no corrective action is envisaged.

Event Description

On (b)(6) 2017: implantation of the access port via the right cephalic vein.On (b)(6) 2017: during a medical consultation, exteriorisation of the access port housing detected.Patient transferred to emergency for removal.No other consequences for the patient.

• Brand Name: CELSITE
• Type of Device: ACCESS PORT SYSTEM
• Manufacturer (Section D): B.BRAUN MEDICAL SAS; 204 avenue du marechal juin; boulogne, 92100 ; FR 92100
• Manufacturer (Section G): B.BRAUN MEDICAL SAS; avenue des temps modernes; chasseneuil, 86361 ; FR 86361
• Manufacturer Contact: catherine boismenu ; 30, avenue des temps modernes; chasseneuil du poitou 86360 ; FR 86360
• MDR Report Key: 7137825
• MDR Text Key: 95498537
• Report Number: 9612452-2017-00050
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/04/2022
• Device Model Number: 4430425
• Device Lot Number: 36915838
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR