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

Model Number	5433750
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch history review: the manufacturing file was reviewed.It is compliant with our specifications and no abnormality was detected.No other complaint was reported on this batch of access ports.Investigation: despite requests, nor the involved device nor the x-rays pictures were returned for analysis.No thorough investigation can be performed.Conclusion: no conclusion can be drawn.The complaint handling database does not show any increasing trend for this type of access port.No corrective action is envisaged.Additional note: this initial report is resent today following fda request.The fist report was submitted on may 24th, 2016 but not correctly received by the fda.
Event or Problem Description
Implantation of the access port on (b)(6) 2015.On (b)(6) 2016, removal of the access port due to detection of a leakage.Removal without resistance however one part of the catheter is missing.Patient transferred in another hospital in order to remove the distal part of the catheter by interventional radiology.

• Brand Name: CELSITE
• Common Device Name: 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: 5738583
• Report Number: 9612452-2016-00019
• Device Sequence Number: 16800638
• Product Code: LJT
• UDI-Device Identifier: 04046963594954
• UDI-Public: 04046963594954
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2020

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 Model Number: 5433750
• Device Catalogue Number: 4433750
• Device Lot Number: 36900709
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2016
• Supplement Date Received by Manufacturer: 04/25/2016
• Initial Report FDA Received Date: 06/21/2016
• Supplement Report FDA Received Date: 06/21/2016
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female