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

Model Number	4433750
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/10/2016
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: the device is not available for analysis.No thorough investigation can be performed.The x-ray picture received confirmed the catheter disconnection and migration on (b)(6) 2016 without given any information on its root cause.Conclusion: without the involved device no conclusion can be drawn concerning the cause of the catheter separation.The complaint handling database does not show any increasing trend for this type of access port.It is a known risk of the access port implantation.No corrective action is envisaged.
Event or Problem Description
Disconnection and migration of the catheter, detected before 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, ile de france 92100 ; FR 92100
• MDR Report Key: 5945238
• Report Number: 9612452-2016-00033
• Device Sequence Number: 605223
• Product Code: LJT
• UDI-Device Identifier: 04046963594954
• UDI-Public: 04046963594954
• 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): 09/12/2016

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: Nurse
• Device Expiration Date: 10/14/2020
• Device Model Number: 4433750
• Device Lot Number: 36902686
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2016
• Initial Report FDA Received Date: 09/13/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 95