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

Model Number 4430409

Device Problem Fracture (1260)

Patient Problems Extravasation (1842); Inflammation (1932); Burning Sensation (2146)

Event Type  malfunction  

Event Description

"non-functional right implantable catheter arrives for application day 1 of folfoxiri scheme, under sterile technique cannulation is performed with surecam needle, no return is obtained, we proceed to infuse ssn and there is evidence of superior extravasation at the level of the catheter route and the user also reports a burning sensation.The patient reports that the catheter has not been manipulated since the beginning of this year and that the previous time in the hospital they punctured it but it became inflamed and they did not give her any indication", the patient received incomplete chemotherapy because the 5fu infuser could not be connected, so it is considered a non-serious adverse event, patient pending evaluation by general cx with thorax rx to determine catheter removal.".

Manufacturer Narrative

Note: product reference 4430409 is not cleared for sales in the usa, but it is similar to a product reference cleared under #510k130576.Device history record the batch record file was reviewed: the 150 units of this batch released in november 2022 were manufactured within the specifications and no discrepancy was observed.No other similar complaint was reported on this batch of access ports.Summary of investigation no sample, pictures / videos and x-ray pictures were returned for investigation.Conclusion without the sample for evaluation and x-ray pictures, it is not possible to determine the root cause of this incident.However, the batch history record has not actually revealed failure during manufacturing process.Catheter rupture is a known complication of the access port implantation.This type of incident remains rare (0.01%).No corrective action is currently envisaged.

• 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 86360 ; FR 86360
• Manufacturer Contact: catherine boismenu ; 30 avenue des temps modernes; chasseneuil du poitou 86360 ; FR 86360
• MDR Report Key: 18383591
• MDR Text Key: 331215674
• Report Number: 9612452-2023-00030
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2023

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 Model Number: 4430409
• Device Lot Number: 36999331
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention