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

Model Number 4430092

Device Problems Material Separation (1562); Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Date 04/24/2019

Event Type  Injury  

Manufacturer Narrative

Note: product reference 4430092 is not cleared for sales in the usa, but similar product reference 5430095 is cleared under #510k130576.Batch history review: we have checked the manufacturing file of batch nr m0788990 which complies with our specifications and does not present any discrepancy.Another similar complaint, from the same end customer has been reported to us on this batch of access ports released in april 2013.Investigation results: we did not received the complaint sample for investigation.We received a picture of a "v" type catheter tip, we can see a that the ended valve is missing.X-ray pictures review: we received a ct scan picture.On this picture, we can see a 12mm long piece at the level of the lung.We can hypothesis that this is the catheter valve.Conclusion: the complaint is confirmed, the valve has been disconnected from its catheter.However, without the device for investigation, no thorough investigation is possible and we cannot conclude on the real cause of the valve disconnection.A capa has been implemented in production in september 2018 in order to reinforce the valve holding on the catheter.The batch number involved in the complaint has been manufactured prior to this capa.No further corrective action is envisaged at the moment.B braun (b)(4) has provided all the information currently available to us.In spite of all reasonable efforts being made to obtain further information or the device, at this time we have not met with success.

Event Description

Patient was implanted with celsite access port on (b)(6) 2016 for chemotherapy infusion to treat right breast cancer.On (b)(6) 2019 the access port was removed.After removal, it was found that the catheter valve was lost.Ct image indicated tha there was a 12 mm foreign body located at lower lobe of lung which should be the valve.

• 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: 8651269
• MDR Text Key: 146493222
• Report Number: 9612452-2019-00076
• 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: foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/29/2019

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 Expiration Date: 03/31/2018
• Device Model Number: 4430092
• Device Lot Number: M0788990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/30/2019
• Initial Date FDA Received: 05/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 59 YR