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

Model Number 4430095

Device Problem Contamination /Decontamination Problem (2895)

Patient Problems Post Traumatic Wound Infection (2447); Alteration in Body Temperature (4568)

Event Date 10/21/2020

Event Type  Injury  

Manufacturer Narrative

Note: product reference 4430095 is not cleared in usa, but it is similar to the product reference 5430095 cleared under #510k130576.Batch history review: we have checked the manufacturing file of the involved batch which complies with our specifications and does not present any discrepancy.The sterilization records, the lal and bioburden test results were reviewed.All data are compliant with our requirements.No other similar complaint has been reported to us on this batch of access ports released in june 2020.Investigation: we did not received the complaint sample for investigation.No bacteriological test results have been communicated to us.Conclusion: the received elements do not allow us to conclude on the exact cause of the infection.However as our records shows that this batch of celsite access port has been manufactured, packed and sterilized in compliance with our specifications and validated processes, no other complaint were reported on this batch, we can deduce that this incident is not directly imputable to the device.The ifu gives some recommendations concerning access ports maintenance.The review of the customer complaints database does not show any increasing trend for infection following access port implantation.The global complaint rate for infection on celsite access ports is very low: 0,0006%.No corrective action is envisaged.

Event Description

On (b)(6) 2020, when the patient used the celsite for infusion, she developed cold intolerance and fever.Stopped using infusion port and used peripheral venous infusion instead.The patient was obviously improved.The crp and procalcitonin were significantly increased, and the possibility of bacteremia caused by celsite infection was considered.After the discussion of the department and the consultation of relevant specialists, applied anti-inflammatory treatment.On (b)(6) 2020, the infusion tube was taken out, and bacterial culture was carried out on the catheter, and the result was positive.After the operation, the patient continued anti-inflammatory treatment, and no fever or cold intolerance occurred.After reexamination, crp and procalcitonin decreased significantly, blood culture results were negative, and the patient was discharged smoothly after the condition improved.No sample or picture provided.

• 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 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: 11041305
• MDR Text Key: 222647438
• Report Number: 9612452-2020-00048
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2020

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: 4430095
• Device Lot Number: 36962052
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other