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

Model Number 4430433

Device Problem Fracture (1260)

Patient Problem Burning Sensation (2146)

Event Date 05/31/2021

Event Type  Injury  

Manufacturer Narrative

Note: product reference (b)(4) is not cleared for sales in the usa, but its catheter is similar to the product reference 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.A similar complaint has been reported to us by the same hospital on this batch of access ports released in (b)(6) 2020.Investigation results: we did not received the complaint sample nor the x-ray pictures for investigation.The picture recieved shows a catheter rupture under the connection ring.Conclusion: without the complaint sample or the x-ray pictures for investigation, no thorough investigation is possible and we cannot conclude on the real cause of the incident.If new element become available in the future, we will re-open this complaint.Catheter rupture is a known complication of the access port implantation that could have different root causes.This is a rare incident.No corrective action is currently envisaged.

Event Description

"b.Braun catheter ruptured after use in chemotherapy.The catheter was inserted after diagnosis.In the chemotherapy, the patient felt a burning sensation, and the catheter was removed via hemodynamics, and replaced another catheter with the same brand.".

• 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: 12412174
• MDR Text Key: 269527450
• Report Number: 9612452-2021-00044
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 09/01/2021

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 Operator: Health Professional
• Device Model Number: 4430433
• Device Lot Number: 36970992
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/02/2021
• Initial Date FDA Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR