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

Model Number 4433742

Device Problem Material Rupture (1546)

Patient Problem No Code Available (3191)

Event Date 02/04/2019

Event Type  Injury  

Manufacturer Narrative

Note: product reference 4433742 is not cleared for sales in the usa, but it is similar to the product reference 5433742 cleared under # 510k 130576.Batch history review: we have checked the manufacturing file of batch m269418t of celsite access ports 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 2013.Investigation results: we received for investigation one celsite babyport access port from batch m269418t.Two segments of catheter were returned.Once is still connected to the access port housing.The other part measures 14 cm.The rupture facies is irregular.Conclusion: the information received from the customer allows us to hypothesis that the catheter rupture during its removal, results from an incorporation of the catheter in the vein.The catheter rupture during removal of long-term implantations (2.5 years in this case) is a known complication of access ports with thin catheters.The ifu informs the physician about the implantation duration and the specific precautions to be taken for implantation on children.This is a rare occurrence, no further corrective action is envisaged.

Event Description

On (b)(6) 2019: explantation of the access port.During catheter removal, a resistance is felt.Despite precautions, the catheter broke in 3 pieces in two locations.The distal part is still attached in the vessel.A second endovascular intervention is planned to remove it under local anesthesia.

• 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; 30 avenue des temps modernes; chasseneuil du poitou, 86361 ; FR 86361
• Manufacturer Contact: catherine boismenu ; 30, avenue des temps modernes; chasseneuil du poitou, 86361 ; FR 86361
• MDR Report Key: 8532331
• MDR Text Key: 142517742
• Report Number: 9612452-2019-00066
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 04038653917587
• UDI-Public: 4038653917587
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: 4433742
• Device Lot Number: M269418T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention