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

Model Number 4430095

Device Problem Fracture (1260)

Patient Problem Discomfort (2330)

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.Investigation results: despite requests, we did not receive the product batch, the complaint sample nor x-ray pictures for evaluation.Conclusion; without the complaint sample or x-ray pictures, we cannot conclude on the real cause of this incident.Catheter rupture is a known complication of the access port implantation, documented in the ifu; this is a rare incident, no increasing trend is detectable in our complaint database.Consequently no corrective action is envisaged.

Event Description

In (b)(6) 2022, the catheter was implanted into the infusion port.In (b)(6) 2023, due to infusion pain, it was found that the catheter was broken and removed at another hospital.The patient recovered.The batch number and sample is not available.

• 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: 17764749
• MDR Text Key: 323610855
• Report Number: 9612452-2023-00017
• 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: Other
• Type of Report: Initial
• Report Date: 09/18/2023

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 Model Number: 4430095
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/22/2023
• Initial Date FDA Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention