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

Model Number	4433823
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Swelling (2091)
Date of Event	01/04/2016
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 device is not available for analysis.No thorough investigation can be performed.The x-ray picture received confirmed the catheter disconnection without giving 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.No corrective action is envisaged.Device still implanted into patient.
Event or Problem Description
"the catheter separated from the application device into the patient causing the local bulge.The patient died because he was bearer of a disease (cancer) and was in the terminal phase of the disease.Therefore the family hasn't authorized the removal of the device.Emphasizing that the patient didn't came to death due to what happened to the port".

• 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: 5754433
• Report Number: 9612452-2016-00024
• Device Sequence Number: 16266045
• Product Code: LJT
• UDI-Device Identifier: 04046963594978
• UDI-Public: 04046963594978
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K130576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/24/2016

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: 02/28/2020
• Device Model Number: 4433823
• Device Lot Number: 36896008
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2016
• Initial Report FDA Received Date: 06/28/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Other
• Patient Age: 68 YR