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

Model Number 4433750

Device Problems Disconnection (1171); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 03/22/2019

Event Type  Injury  

Manufacturer Narrative

Note : product reference 4433750 is not cleared for sales in the usa, but similar product reference 5433750 is cleared under #510k130576.Batch history review: we have checked the manufacturing file of batch nr36938887of celsite access ports which complies with our specifications and does not present any discrepancy.No other similar complaint has been reported to us on this batch of (b)(4) access ports released in october 2017.Investigation results: the complained sample nor x ray pictures were returned for investigation.Conclusion: without any element for the investigation, we cannot conclude on the root cause of this incident.However if new elements become available, this complaint will be re-opened.This is a rare incident.No corrective action is currently envisaged.B braun (b)(4) has provided all the information currently available to us.In spite of all reasonable efforts being made to obtain further information or the device, at this time we have not met with success.

Event Description

Catheter disconnection and migration into the heart.

Manufacturer Narrative

Batch history review: we have checked the manufacturing file of batch 36938887 of celsite st305 which complies with our specifications and does not present any discrepancy.No other incident has been reported to us on this batch of access ports released in october 2018.Investigation results: we received for investigation one celsite st305 access port from batch 36938887 with its connection ring and a catheter cut into 2 pieces: one 20.8 cm long piece and a 0.4 cm long pieces still on the exit cannula.The catheter rupture occurred under the connection ring.The rupture facies is partially cut clear.This part of the catheter is protected by the connection ring during implantation period.Dimensional measures: we have measured the returned device in order to check its conformity to our specifications.All the measures conform to our specifications.Conclusion: no manufacturing defect has been detected on the returned device.The catheter rupture occurred under the connection ring, shortly (<3 months) after the implantation.According to the above mentioned information and in view of the location of the catheter rupture, we think that the catheter rupture is due to the extension of a catheter damaged done during the implantation procedure, probably while mounting the catheter on the exit cannula.The ifu specifies: "during implantation ensure that the catheter is not damaged by unguarded forceps, suture needle or other sharp object." this is a rare incident, no corrective action is envisaged.

• Brand Name: CELSITE
• Type of Device: ACCESS PORT SYSTEM
• Manufacturer (Section D): B.BRAUN MEDICAL SAS; 26 rue armengaud; saint cloud 92210 ; FR 92210
• MDR Report Key: 8524143
• MDR Text Key: 142256656
• Report Number: 9612452-2019-00065
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 04038653917594
• UDI-Public: 4038653917594
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 05/03/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2023
• Device Model Number: 4433750
• Device Lot Number: 36938887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Initial Date Manufacturer Received: 03/22/2019
• Initial Date FDA Received: 04/17/2019
• Supplement Dates Manufacturer Received: 03/22/2019
• Supplement Dates FDA Received: 05/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 86