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

Model Number 4433742

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  malfunction  

Event Description

"1 port operated on 1 child.Started bleeding during surgery.".

Manufacturer Narrative

Note: product reference (b)(4) is not cleared for sales in the usa, but it is similar to a product reference cleared under #510k130576.Batch history review: we have checked the manufacturing file of the involved batch of celsite babyport which complies with our specifications and does not present any discrepancy.No other incident has been reported to us on this batch of celsite babyport released in (b)(6) 2018.Investigation results: we received for investigation one celsite babyport from batch 36932849 with the catheter into two pieces and its connection ring.Visual exam: the silicone membrane show a lot of puncture marks.That's proves that the access port was implanted several years on the child.The proximal part of the catheter measures 9 cm.It is still connected to the port.The second segment is the distal part of the catheter.It measures 5.3 cm.The catheter rupture occured at 9 cm from the access port.The facies is rough, calcified and torn.Some fibrin/tissue residues are visible on the received sample.No manufacturing defect is visible on the returned elements.The received elements allow us to assume that the catheter was encapsulated into the vessel wall at the moment of the removal.Conclusion: the evaluation of the explanted device shows no manufacturing defect.The incident seems to be due to an encapsulation/adhesion of the catheter into the vessel wall which have led to a rupture during removal.This is a known complication of the access port implantation, especially on children when the poulyurethane catheter was implanted during several years and the distal catheter extremity becomes placed too high in the ivc.The ifu informs the physician about the implant duration and the specific precautions to be taken for implantation on children.The catheter rupture during removal of long-term implantations is a known complication of access ports with thin catheters.This is a rare occurrence, no further corrective action is envisaged at the moment.

• Brand Name: CELSITE
• Type of Device: ACCESS PORT SYSTEM
• Manufacturer (Section D): B.BRAUN MEDICAL SAS; 26 rue armengaud; saint cloud, 92210 ; FR 92210
• Manufacturer (Section G): B.BRAUN MEDICAL SAS FRANCE; 30 avenue des temps modernes; chasseneuil du poitou 86360 ; FR 86360
• Manufacturer Contact: catherine boismenu ; 30 avenue des temps modernes; chasseneuil du poitou, 86360 ; FR 86360
• MDR Report Key: 15615418
• MDR Text Key: 307575543
• Report Number: 9612452-2022-00048
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): Y
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2023
• Device Model Number: 4433742
• Device Lot Number: 36932849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2022
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other