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

Model Number	4430425
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/15/2016
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 similar complaint was reported on this batch of access ports.Investigation: neither the involved device nor the x-ray pictures were returned for analysis.No thorough investigation can be performed.Conclusion: without the involved device no conclusion can be drawn concerning the cause of the catheter disconnection.It is a known complication of access port implantation.No corrective action is envisaged.
Event or Problem Description
On (b)(6) 2016: implantation of an access port via the right subclavian vein.The correct catheter connection was confirmed.On (b)(6) 2016: during the second chemotherapy administration, disconnection fo the catheter is noted.The catheter was removed by femoral approach due to its migration in the vena cava.On (b)(6) 2016: explantation of the access port and placement of a second one.Remark: no problem during the administration of the first chemotherapy treatment.

• Brand Name: CELSITE
• Common Device Name: ACCESS PORT SYSTEM
• Manufacturer (Section D): B.BRAUN MEDICAL SAS - OWNER; 204 avenue du marechal juin; boulogne billancourt, 92100 ; FR 92100
• MDR Report Key: 5999949
• Report Number: 9612452-2016-00036
• Device Sequence Number: 13662839
• Product Code: LJT
• UDI-Device Identifier: 04046963594817
• UDI-Public: 04046963594817
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: user facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 10/04/2016

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: 02/28/2016
• Device Model Number: 4430425
• Device Lot Number: 36906892
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2016
• Initial Report FDA Received Date: 10/05/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention