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

Model Number 443000

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/13/2020

Event Type  Injury  

Manufacturer Narrative

Product reference 4430000 is not cleared for sales in the usa, but its catheter is similar to the product reference 5436717 cleared under #510k130576.Batch history review: we have checked the manufacturing file of the involved batch which complies with our specifications and does not present any discrepancy.Another similar complaint has been reported to us on this batch of access ports released in december 2015.Investigation results: we received for investigation a celsite access port nr 36903717 with the proximal part of the catheter.This segment measures 4.2 cm.At the level of the rupture, the catheter presents marks of pinch or kink.Dimensional measurements: we have measured the returned catheter in order to check its conformity to our specification.The internal and external diameters conform to our requirements.Conclusion: the catheter rupture is probably due to a kink or a pinch of the catheter.Only the examination of the x-ray pictures could confirm this hypothesis.The evaluation of the explanted device did not allow us to detect any manufacturing defect on the device.The ifu specifies to ensure there is no kinking of the catheter during the implantation procedure.The risk of catheter rupture is a known complication of the access port implantation.The complaint rate is low (<0,01%).No manufacturing defect has been detected on the returned sample.Consequently, no corrective action is envisaged.

Event Description

"the (b)(6) hospital in (b)(6), had a rupture of the silicone tube during the explantation of our port system.During the explantation of the celsite port t301, the silicone tubing was torn off and a residue remains in the vessel.".

• Brand Name: CELSITE
• Type of Device: ACCCESS 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: 9823404
• MDR Text Key: 196395667
• Report Number: 9612452-2020-00011
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/23/2020
• Device Model Number: 443000
• Device Lot Number: 36903717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2015
• 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