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

Model Number 4430893

Device Problem Material Integrity Problem (2978)

Patient Problems Pain (1994); Swelling (2091)

Event Date 10/18/2017

Event Type  Injury  

Manufacturer Narrative

Note: product reference 4430893 is not cleared for sales in the usa, but it is similar to the product reference 5433750 cleared under #510k130576.Batch history review: the manufacturing file was reviewed.It is compliant with the specifications and no abnormality was detected during production.No other complaint has been reported on this access port batch sold since august 2017.Investigation: the device was not returned for evaluation.The xray pictures are inconclusive for the root cause of the catheter rupture.Conclusion: without device, no conclusion can drawn on the root cause of the incident.As a rare incident, no corrective action is envisaged.

Event Description

At the time of the injection by the nurse, no venous return detected.Injection performed and immediate pain and edema noticed above the access port.Explantation of the access port.During this explantation, the catheter migrated and required the patient's transfer to another hospital for ablation.

• Brand Name: CELSITE
• Type of Device: ACCESS PORT SYSTEM
• Manufacturer (Section D): B.BRAUN MEDICAL SAS; 204 avenue du marechal juin; boulogne, 92100 ; FR 92100
• Manufacturer (Section G): B.BRAUN MEDICAL SAS; avenue des temps modernes; chasseneuil, 86361 ; FR 86361
• Manufacturer Contact: catherine boismenu ; 30, avenue des temps modernes; chasseneuil du poitou 86360 ; FR 86360
• MDR Report Key: 7137842
• MDR Text Key: 95481356
• Report Number: 9612452-2017-00051
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 05/03/2022
• Device Model Number: 4430893
• Device Lot Number: 36919565
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 50