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

Catalog Number	4430146
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/23/2015
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: the involved device was discarded and not availbale for evaluation.X-ray examination: the review of x-rays picture taken just after implantation ((b)(6) 2015) shows that the catheter does not appear to have been correctly positioned on the port exit cannula during the implantation procedure.Conclusion: the disconnection of the catheter, observed 5 months after the device implantation, is probably due to incorrect connection of the catheter to the port by user.No corrective action is envisaged.
Event or Problem Description
On (b)(6) 2015: implantation of the access port system without difficulties.On (b)(6) 2015: catheter disconnected from the port.
Additional Manufacturer Narrative
The additional information concerning the patient, received after the first medwatch report, does not changed the conclusion of the investigation.

• 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: 5519184
• Report Number: 9612452-2016-00012
• Device Sequence Number: 13535769
• Product Code: LJT
• UDI-Device Identifier: 04046963594763
• UDI-Public: 04046963594763
• 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: other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2016

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: Physician
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 4430146
• Device Lot Number: 36895116
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2016
• Supplement Report FDA Received Date: 04/11/2016
• 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: 69 YR