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

Catalog Number	4433842
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch history review: the batch history review was performed.The batch has been manufactured in compliance with our specifications and does not present any discrepancy.No other incident has been declared.This batch of access ports released in june 2014.Investigation results: we received for investigation a celsite babyport housing from batch n146786t, connected to a 15.4 cm long catheter with a connection ring.The device is contaminated by blood.Observations: no defect is visible on the returned device.The device dimensionally conforms to the specifications.X-ray pictures examination: on (b)(6) 2016 - this picture shows the implantation of the babyport.The catheter tip is located high in the superior vena cava.It is worth noting that the ifu's specify placing the catheter tip to the entrance of the right atrium entry.On (b)(6) 2016 - 4hrs after implantation: the catheter forms a zigzag near the housing.The catheter tip has moved to the patient's neck.The access port housing is still at the same location.On (b)(6) 2016 = catheter has been replaced in the superior vena cava.The catheter tip is still placed high in the superior vena cava.On (b)(6) 2016 = the catheter forms a loop near the access port housing.The catheter tip is located in the patient's neck.Conclusion: no defect has been detected on the returned sample.The cause of the catheter displacement could not be determined precisely.Such loops created in the catheter is totally unusual.However it is known that a short catheter, placed high in the svc favors catheter tip movements.We can venture the hypothesis of traction on the catheter or of the access port by the patient.This is an isolated case, no corrective action is envisaged.
Event or Problem Description
Access port system catheter was inserted through subclavian vein using open surgery technique on (b)(6) 2016.When the doctor tried to access the port using port needles after 4 hours, the fluid tended to leak out.They performed chest x-ray and found out it was due to catheter tip displacement to the neck.Doctor decided to readjust the catheter tip position on (b)(6) 2016.However on (b)(6) 2016, the catheter tip displaced again from svc to patient's neck.Doctor decided to remove the babyport and implant a new celsite st 305 access 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: 5754432
• Report Number: 9612452-2016-00025
• Device Sequence Number: 21419
• Product Code: LJT
• UDI-Device Identifier: 04046963594947
• UDI-Public: 04046963594947
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/27/2016

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: Physician
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 4433842
• Device Lot Number: N146786T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2016
• Initial Report FDA Received Date: 06/28/2016
• 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: 11 MO