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

Model Number 4430018

Device Problem Fluid/Blood Leak (1250)

Patient Problems Extravasation (1842); Necrosis (1971)

Event Date 01/26/2021

Event Type  Injury  

Manufacturer Narrative

Note : product reference 4430018 is not cleared for sales in the usa, but similar product cleared under #510k130576.Batch history review: we have checked the manufacturing file of batch nr36963918 which complies with our specifications and does not present any discrepancy.No other similar complaint has been reported to us on this batch of access ports released in may 2020.Investigation results: we did not received the complaint sample or x-ray films for investigation.Conclusion: without the complaint sample for investigation no thorough investigation is possible and we cannot conclude on the real cause of the incident.If new element become available in the future, we will reopen this complaint.The complaint rate is low (<0,01 %).No corrective action is envisaged at the moment.

Event Description

Necrosis due to durg extravasation.

• 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 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: 11377798
• MDR Text Key: 233457547
• Report Number: 9612452-2021-00013
• 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: Other
• Type of Report: Initial
• Report Date: 02/25/2021

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: No Information
• Device Model Number: 4430018
• Device Lot Number: 36963918
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 02/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other