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

Model Number 4430395

Device Problem Expulsion (2933)

Patient Problem Impaired Healing (2378)

Event Date 03/01/2024

Event Type  Injury  

Manufacturer Narrative

Note: product reference (b)(4) is not cleared for sales in the usa, but it is similar to a product reference cleared under #510k130576.Batch history review: batch unknown.Investigation results: the device was not returned for evaluation.However a picture of the event was forwarded.We can see the access port implanted in the patient's chest: the access port housing is visible through the skin.The patient skin/scare over the access port is pierced and dry.No swelling is visible.We can see that the access port housing is located under the implantation scar.Conclusion: the access port exteriorization observed is a known complication of access port implantation.The image received seems to show that two factors could have contributed to this incident: - the fact that the access port housing was implanted just under the skin incision, not at one centimeter of the skin incision as recommended.The ifu specifies: vi-1-1 k) "ensure that the skin incision is 1 cm from the injection site." - the fact that the access port was implanted too superficially: the ifu specifies: vi-1-1 "f) prepare the port pocket at the chosen site, the port should lie approximately 1/2 - 1 cm below the skin surface away from the injection site." this is a rare incident not directly imputable to the device, no corrective action is envisaged for the moment.

Event Description

Patient undergoing systemic management with highly toxic chemotherapy with flot scheme, comes for 3rd cycle administration showing evidence of dehiscence of the pocket wound of the implantable catheter with exposure of the device.It is not possible to use this access under these conditions, patient would require hospitalization to change the catheter and complete infusion of 5 fluorouracil.

• Brand Name: CESLITE
• 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: 19141759
• MDR Text Key: 340567086
• Report Number: 9612452-2024-00013
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4430395
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization
• Patient Age: 34 YR
• Patient Sex: Female