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

Catalog Number	4430146
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/07/2016
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: despite requests, nor the involved device nor the x-rays pictures were returned for analysis.No thorough investigation can be performed.Conclusion: no conclusion can be drawn.Our complaint database does not show any increasing trend for this type of access port.No corrective action is envisaged.
Event or Problem Description
Disconnection of the catheter from the access port, less than 2 months after the implantation.Removal of the catheter performed in an other hospital.

• Brand Name: CELSITE DISCREET
• 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: 5418549
• Report Number: 9612452-2016-00005
• Device Sequence Number: 644765
• Product Code: LJT
• UDI-Device Identifier: 04046963594763
• UDI-Public: 04046963594763
• 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 Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Pharmacist
• Report Date (Section B): 02/08/2016

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: 09/23/2020
• Device Catalogue Number: 4430146
• Device Lot Number: 36901871
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2016
• 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