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

Model Number 4433750

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Swelling/ Edema (4577)

Event Date 04/26/2022

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 nr36977615 which complies with our specifications and does not present any discrepancy.No other similar complaint has been reported to us on this batch of access ports released in april 2021.Investigation results: the complaint sample was not sent for investigation.We received pictures of the explanted device.On these pictures, we can see the explanted access port housing, the connection ring and a catheter not connected to the port.We dintinguish a small piece of catheter still mounted onto the exit cannula.This allows us to hypothesis that the catheter rupture occurred at the level of the access port exit cannula.No evidence on the origin of the catheter rupture is visible on the received picture.Test on sample from the same batch: we have measured and performed mechanical tests on a reserve sample from the same batch in order to check its conformity to our specifications.All these measures and results are compliant with the specifications / requirements.Conclusion: the received pictures allows us to see a small piece of catheter still connected, it is highly suspected that the catheter rupture occurred on the access port exit cannula, however without the complaint sample for investigation no through investigation is possible and we cannot conclude on the real cause of the catheter rupture.This is a rare incident, no corrective action is envisaged for the moment.

Event Description

"dr.(b)(6) put the b braun port (6.5fr s size) on (b)(6) 2021 in patient ; on (b)(6) 2022, when he triied to give chemotherapy, he found the injected part swollen.Through f/u x-ray he found porta seperated from the catheter.In the same day, he took away the port a and catheter away from the patient's body and returned the object to b braun.".

• 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: 14644269
• MDR Text Key: 294808672
• Report Number: 9612452-2022-00024
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 4433750
• Device Lot Number: 36977615
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 18 KG