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

Model Number 4430395

Device Problem Expulsion (2933)

Patient Problems Bacterial Infection (1735); Purulent Discharge (1812)

Event Date 03/11/2024

Event Type  Injury  

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: batch unknown.Investigation results: the device was not returned for evaluation.No picture of the event was supplied.No thorough investigation is possible.Conclusion: the access port exteriorization is a known complication of access port implantation.Without any element for investigation it is not possible to determine the root cause of this event.The raw material used, the manufacturing, cleaning and sterilization processes have not changed in recent months/years.There is no increasing trend in the reporting of such event.The main documented root causes of exteriorisation are: - allergy, infection, important patient weight loose.- the fact that the access port housing was implanted just under the skin incision, not at one centimeter of the skin incision as recommended.The ifu specifies: vi-1-1 k) "confirm catheter patency (by ensuring that both aspiration and injection are possible), ensure that the skin incision is 1 cm from the injection site." - the fact that the access port was implanted too superficially: the ifu specifies: vi-1-1 "f) prepare the port pocket at the chosen site, the port should lie approximately 1/2 - 1 cm below the skin surface away from the injection site." - poor maintenance this is a rare incident, no corrective action is envisaged.

Event Description

Patient with dehiscence of implantable catheter wound, with scarce seropurulent secretion, without signs of cellulitis, denies fever, denies bleeding, denies other symptoms.The infusion of 4 fu is deferred, the rest of the scheme is started by peripheral vein, it is discussed with the treating oncologist and coordinator, it is defined to prioritize catheter change in the course of the week, antibiotic coverage is indicated according to specialist recommendations.

• 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: 19141760
• MDR Text Key: 340567088
• Report Number: 9612452-2024-00014
• 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: 04/19/2024

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 Model Number: 4430395
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization
• Patient Age: 41 YR
• Patient Sex: Female