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

Model Number 4433750

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 04/27/2020

Event Type  malfunction  

Manufacturer Narrative

Note : product reference 4433750 is not cleared for sales in the usa, but similar product reference 5433750 is cleared under #510k130576.Batch history review: we have checked the manufacturing file of the involved batch which complies with our specifications and do not present any discrepancy.No other similar complaint has been reported to us on this batch of access ports released in march 2020.Investigation: the device was not returned for evaluation.Conclusion: with the information we have, no thorough investigation can be performed and no conclusion can be drawn.If new element is received, the file will be reopen.

Event Description

"port implant: local anesthesia, echoguided puncture of the right internal jugular vein.Introduction of guide wire and subsequently of dilator according to seldinger technique following the guide.Dilator removal and catheter introduction.Subcutaneous pocket created.Surface suture.Intervention duration approximately 30 minutes.The metal guide is equipped with a curved tip with an elastic u to protect the vessels in which it is introduced during the advance.The failure to return the tip elastically has probably resulted in the transfixion of the inner jugular vein, lasso tissue and the right subclavia artery.Following the guide, the catheter was implanted in the aforementioned artery.".

• Brand Name: CELSITE
• Type of Device: ACCESS PORT
• 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: 10154053
• MDR Text Key: 196833799
• Report Number: 9612452-2020-00019
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 06/12/2020

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 Model Number: 4433750
• Device Lot Number: 36959437
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2020
• Initial Date FDA Received: 06/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2020
• 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): Other
• Patient Age: 50 YR