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

Model Number 4430147

Device Problem Material Rupture (1546)

Patient Problem Pain (1994)

Event Date 03/19/2019

Event Type  Injury  

Manufacturer Narrative

Product reference 4430147 is not cleared for sales in the usa, but similar product reference 5430146 is cleared under #510k130576.Batch history review: we have checked the manufacturing file of batch nr36936511 of 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 september 2018.Investigation results: we did not receive the involved sample nor x ray pictures to be able to perform an 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

During the administration of the second treatment, it was discovered that the catheter was ruptured.Pain during injection.A x-ray exam showed that the catheter moved in the svc / right atrium.Catheter removed on (b)(6) 2019.Access port removed on (b)(6) 2019.

• 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, 86361 ; FR 86361
• Manufacturer Contact: catherine boismenu ; 30, avenue des temps modernes; chasseneuil du poitou, 86361 ; FR 86361
• MDR Report Key: 8575827
• MDR Text Key: 143934909
• Report Number: 9612452-2019-00067
• Device Sequence Number: 1
• Product Code: LJT
• 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: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2023
• Device Model Number: 4430147
• Device Lot Number: 36936511
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2018
• 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
• Patient Age: 84 YR