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	03/04/2016
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: the involved device was returned for evaluation.It has been measured.All the dimensions complied to the specifications.A disconnection test between the catheter and the housing was performed.The results are more than 4 times greater than the standard requirement.Conclusion: the returned device is compliant with the specifications.No failure has been detected.The disconnection of the catheter observed three weeks 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) 2016 port implantation on the cephalic vein.On (b)(6) 2016 discovery of the catheter disconnection from port.On (b)(6) 2016 port explantation.

• 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: 5597192
• Report Number: 9612452-2016-00017
• Device Sequence Number: 362983
• 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: 2016
• Device Explanted Year: 2016
• 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: 10/14/2020
• Device Catalogue Number: 4432452
• Device Lot Number: 36902358
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2016
• Initial Report FDA Received Date: 04/22/2016
• 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: 71 YR