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

Model Number 4436709

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 03/29/2021

Event Type  malfunction  

Manufacturer Narrative

Note: product reference 4436709 is not cleared for sales in the usa, but it is similar to the product reference 5436709 cleared under #510k130576.Batch history review: we have checked the manufacturing file of the involved batch which complies with our specifications and does not present any discrepancy.No other similar complaint has been reported to us on this batch released in january 2019.Investigation: despite our requests, the device nor x-rays films were returned for analysis.Conclusion: the information received are not sufficient to determine the root cause of this incident.This type of incident is a known potential complication of the implantation of access ports.The ifu informs the user about this risk.This is a rare incident.No corrective action is envisaged.

Event Description

"the port was inserted on (b)(6) 2021 by dr (b)(6).Unplanned ot visit (b)(6) 2021; replacement of portacath (port was still in place & 3 fixation sutures in place) catheter had separate from the port.Catheter in l innominate, repositioned/replaced into svc".

• Brand Name: CELSITE
• Type of Device: ACCESS PORT SYSTEM
• Manufacturer (Section D): B.BRAUN MEDICAL SAS; 26 rue armengaud; saint cloud, 92210 ; FR 92210
• Manufacturer (Section G): B.BRAUN MEDICAL SAS FRANCE; 30 avenue des temps modernes; chasseneuil du poitou 86360 ; FR 86360
• Manufacturer Contact: catherine boismenu ; 30 avenue des temps modernes; chasseneuil du poitou, 86360 ; FR 86360
• MDR Report Key: 11983237
• MDR Text Key: 255711108
• Report Number: 9612452-2021-00024
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2024
• Device Model Number: 4436709
• Device Lot Number: 36942131
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 06/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2019
• 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: 16 YR
• Patient Weight: 56