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

Catalog Number	4432452
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/06/2015
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.Our complaint database does not show any increasing trend for this type of access port.No corrective action is envisaged.Confidential note: this file was previously sent in may 2016.Due to undetected report failure, we now resubmit the report.
Event or Problem Description
On (b)(6) 2015 port implantation on the left cephalic vein; on (b)(6) 2015 discovery of the catheter disconnection from port; on (b)(6) 2015 port explantation; on (b)(6) 2015 port implantation in right subclavian vein.

• Brand Name: CELSITE
• Common Device Name: ACCESS PORT SYSTEM
• Manufacturer (Section D): B.BRAUN MEDICAL SAS - OWNER; 204 avenue du marechal juin; boulogne billancourt, ile de france 92100 ; FR 92100
• MDR Report Key: 6343018
• Report Number: 9612452-2016-00015
• Device Sequence Number: 13637604
• Product Code: LJT
• UDI-Device Identifier: 04046963594893
• UDI-Public: 04046963594893
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K130576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2016

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
• Operator of Device: No Information
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 4432452
• Device Lot Number: 36892342
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2016
• Initial Report FDA Received Date: 02/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR