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

Model Number 4436709

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Fever (1858)

Event Type  Injury  

Manufacturer Narrative

Both manufacturing process records and sterilization process records have been reviewed and no discrepancies were found in the manufacturing file of this batch of access ports lal and sterility test results were within specifications.No other complaint has been reported to us on this batch of access ports released in march 2016.In addition, the bacteria "burkholderia cepacia" at the origin of the infection has never been identified on one of our products.As this complaint is an isolated case and as the infection does not seems to be imputable to the device, no corrective action is envisaged.

Event Description

"the patient was a female and a breast cancer patient.Chemoport was inserted under aspectic conditions.However, before they could access for chemotherapy, the patient started having fever with chills and investigations revealed primary port infection.The blood culture from the port showed growth of "burkholderia cepacia." the port had to be removed.".

• Brand Name: CELSITE
• Type of Device: ACCESS PORT SYSTEM
• Manufacturer (Section D): B .BRAUN MEDICAL SAS; 204 avenue du marechal juin; boulogne billancourt, 92100 ; FR 92100
• Manufacturer (Section G): B.BRAUN MEDICAL SAS; 30 avenue des temps modernes; chasseneuil, 86361 ; FR 86361
• Manufacturer Contact: catherine boismenu ; 30 avenue des temps modernes; chasseneuil, 86361 ; FR 86361 ; 49627621
• MDR Report Key: 6493254
• MDR Text Key: 72836852
• Report Number: 9612452-2017-00018
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2021
• Device Model Number: 4436709
• Device Lot Number: 36906382
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention