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

Model Number 4430893

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Purulent Discharge (1812); Extravasation (1842); Chills (2191); Skin Infection (4544); Implant Pain (4561)

Event Date 10/17/2023

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.Investigation results: despite several reminders, the necessary information permitting the investigation was not obtained.Indeed, no bacteriological test results have been communicated and the complaint sample was not returned.The sent picture only shows the batch number of the implanted celsite safety and is not conclusive compared to the complaint description.Historical data review.The review of the customer complaints database does not show any increasing trend for infection following access port implantation.Conclusion.The available elements are not sufficient to identify the root cause of the infection.However, as: the records show that this batch of celsite access port was manufactured, packed, and sterilized in compliance with the defined specifications and according to validated processes.No other complaint was reported on this batch.The incident was discovered 20 days after implantation.This incident seems not directly imputable to the device.The global complaint rate for infection on celsite access ports is very low.No corrective action is foreseen at that time.

Event Description

42-year-old patient treated with chemotherapy for metastatic lung carcinoma who implanted on (b)(6) 2023.Implantable catheter chamber.On (b)(6) 2023 a haematoma opposite the scar was present.The stitches were to be removed planned for d10 (around (b)(6) 2023).During hospitalization for the 2nd course of chemotherapy, on (b)(6) 2023, the patient reported: shoulder pain and the onset of shivering when the stitches were removed.When the dressing was removed, a major disunion with purulent discharge and exposure of the exposure of the implantable chamber.Emergency transfer to the operating theatre for removal and insertion of an iodoformed iodoform.The catheter tip was sent to bacteriology.Culture identified staphylococcus aureus 10*3 cfu/ml.The report was sent to the hygiene department for investigation.

• 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: 18291074
• MDR Text Key: 330046269
• Report Number: 9612452-2023-00027
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 12/08/2023

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: 4430893
• Device Lot Number: 37013036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 12/08/2023
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male