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

Model Number 4433750

Device Problem Fracture (1260)

Patient Problem Edema (1820)

Event Date 08/16/2019

Event Type  Injury  

Manufacturer Narrative

Product reference 4433750 is not cleared for sales in the usa, but its catheter is similar to the product reference 5433750 cleared under #510k130576.Batch history review: we have checked the manufacturing file of batch nr 36901928 which complies with our specifications and does not present any discrepancy.No similar complaint has been reported to us on this batch of access ports released in october 2015.Investigation results: we did not received the complaint sample nor the x-ray pictures for investigation.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.This is a rare incident ((b)(4)%).No corrective action is currently envisaged.

Event Description

Catheter breakage 4 mm length to the camera.The patient had peripheral edema in the access port area due the catheter breakage.

• 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: 9314148
• MDR Text Key: 184880985
• Report Number: 9612452-2019-00102
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 04038653917594
• UDI-Public: 4038653917594
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2020
• Device Model Number: 4433750
• Device Lot Number: 36901928
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2015
• 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): Other
• Patient Age: 71 YR