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

Model Number 4433750

Device Problems Mechanical Problem (1384); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2022

Event Type  Injury  

Manufacturer Narrative

Note: product reference 4433750 is not cleared for sales in the usa, but it is similar to the product reference 5433750 cleared under #510k130576.Batch history review: we have checked the manufacturing file of batch nr 36987931 which complies with our specifications and does not present any discrepancy.A similar complaint has been reported to us by the same end user (9612452-2022-00030) on this batch of access ports released in december 2021.Investigation results: despite requests, we did not receive the complaint sample or the x-ray pictures for investigation.Conclusion: without the complaint sample or the x-ray pictures for investigation, no thorough investigation is possible and we cannot conclude on the real cause of the incident.If new element become available in the future, we will reopen this complaint.This is a rare incident (<0.01%), no corrective action is envisaged for the moment.

Event Description

The catheter disconnects from the housing and goes into the bloodstream.Removal needed by an angiography.

• 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: 14945443
• MDR Text Key: 295419294
• Report Number: 9612452-2022-00031
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): Y
• Reporter Country Code: FR
• 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: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 4433750
• Device Lot Number: 36987931
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2021
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention