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

Model Number 4430095

Device Problem Fracture (1260)

Patient Problem Swelling/ Edema (4577)

Event Date 10/25/2022

Event Type  Injury  

Event Description

"description of malfunction/failure:port catheter ruptured 15 cm description of event:at 15:10 on (b)(6) 2022, the nurse prepared to infuse glucose and sodium chloride injection according to the doctor 's advice, because the infusion port was planned to be used for chemotherapy on the next day.The infusion port was used after communication with the patient.The puncture was smooth without damage to the needle, but there was no blood return during the injection, so the nurse assisted the patient to change position and adjust the angle of the non-invasive needle without blood return.The patient had no complaints of discomfort, and was connected to intravenous drip of sodium chloride solution, with slow dripping speed, 30gtt/min.The head nurse went to the bedside to check.When 20 ml syringe was used to slowly inject normal saline, subcutaneous swelling was found in the right neck, considering catheter rupture.The doctor in charge was informed.At 16:10 pm on the same day, bedside b ultrasound examination was requested to determine that the catheter ruptured in the internal jugular vein segment.The patient 's port has been in place for three years and maintained on time during the period of indwelling, all of which could be used normally without previous abnormalities.On (b)(6) 2022-17:30, the patient removed the infusion port at the breast surgery department, and it was confirmed that there was a rupture at 15 cm of the port catheter.Picc was indwelled in the catheterization lab for subsequent treatment.".

Manufacturer Narrative

Note: product reference (b)(4) is not cleared for sales in the usa, but it is similar to a product reference cleared under #510k130576; batch history review: we have checked the manufacturing file of batch nr 36943462 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 february 2019.Investigation results: despite our requests, we did not receive the complaint sample nor x-ray pictures for investigation.Conclusion: the received elements do not allow us to conclude on the root cause of the catheter rupture reported by the user.If new elements become available in the future, we will reopen this complaint.This is a rare incident and known complication of the access port implantation; no corrective action is envisaged for the moment.

• 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: 16002283
• MDR Text Key: 305681873
• Report Number: 9612452-2022-00056
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 01/30/2024
• Device Model Number: 4430095
• Device Lot Number: 36943462
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2019
• 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
• Patient Age: 66 YR
• Patient Sex: Female