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

Model Number 4433750

Device Problem Insufficient Information (3190)

Patient Problem Swelling/ Edema (4577)

Event Date 07/09/2021

Event Type  malfunction  

Manufacturer Narrative

Note: product reference (b)(4) is not cleared for sales in the usa, but it is similar to the product reference (b)(4) 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 april 2019.Investigation: 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

Swelling visible around the access port + no blood venous return.Patient could not receive his chemotherapy.Urgent intervention in interventional radiology.

Manufacturer Narrative

The involved device has been evaluated.All the measures are complaint with specifications.The leakproff test does not show any leakage.The disconnection test performed between the catheter and the port gives results compliant with our requirements.Conclusion: the returned device does not repsent any failure which could explain the event.

Event Description

Swelling visible around the access port + no blood venous return.Patient could not receive his chemotherapy.Urgent intervention in interventional radiology.

• Brand Name: CELSITE
• Type of Device: ACCESS PORT SYSTYEM
• Manufacturer (Section D): B.BRAUN MEDICAL SAS FRANCE; 30 avenue des temps modernes; chasseneuil du poitou 86360 ; FR 86360
• MDR Report Key: 12217373
• MDR Text Key: 263130712
• Report Number: 9612452-2021-00031
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 10/04/2021

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 Model Number: 4433750
• Device Lot Number: 36978609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2021
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 07/23/2021
• Supplement Dates Manufacturer Received: 07/19/2021
• Supplement Dates FDA Received: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention