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

Model Number 4430095

Device Problems Crack (1135); Fracture (1260)

Patient Problem Swelling/ Edema (4577)

Event Date 10/27/2022

Event Type  malfunction  

Manufacturer Narrative

Note: product reference 4430095 is not cleared for sales in the usa, but it is similar to a product reference cleared under #510k130576.Batch history review: we have checked the manufacturing file of batch nr 36958054 which complies with our specifications and does not present any discrepancy.Another similar complaint (b)(4): same customer, same dates, same description, nmpa report numbers different) was reported to us on this batch of access ports released in february 2020.Investigation results: we did not receive the complaint sample nor 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 this incident.If new elements become available in the future, we will reopen this complaint.This is a rare incident.Catheter rupture is a known complication of access port implantation.No corrective action is envisaged for the moment.

Event Description

"description of event:on (b)(6) 2022, the patient was admitted to the hospital.On (b)(6) the infusion port was maintained to draw blood and pass fluid smoothly.The infusion process was smooth without special abnormalities.On (b)(6) 2022, the patient was found to have subcutaneous tissue swelling in the right neck and right chest during the infusion using the port.It was considered to be port catheter rupture.Color doppler ultrasonography was performed, and abnormal echo of the neck catheter was found.It was considered to be catheter rupture.Magnesium sulfate wet compress was given to the neck and chest, and the local edema subsided.On (b)(6) 2022, the venous access port was removed, the port body and catheter were completely removed, and 2 ruptures of the catheter were found.At present, the patient was in stable condition, picc catheter was implanted, and intravenous chemotherapy was performed, and the process went smoothly.This event was common liquid, which did not cause serious event; if it was chemotherapy drugs, it might cause permanent body damage.The patient developed subcutaneous swelling in the right neck and chest after port infusion, which was considered to be exudation caused by port catheter rupture.Color doppler ultrasound showed catheter rupture, which was confirmed to be catheter rupture after removal.

• Brand Name: CELSITE
• Type of Device: ACCESS PORT SYSTEM
• Manufacturer (Section D): B.BRAUN MEDICAL SAS FRANCE; 30 avenue des temps modernes; chasseneuil du poitou 86360 ; FR 86360
• 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: 16111848
• MDR Text Key: 308641249
• Report Number: 9612452-2023-00001
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2023

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 Model Number: 4430095
• Device Lot Number: 36958054
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female