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

Model Number 4433742

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 02/01/2022

Event Type  Injury  

Manufacturer Narrative

Note: product reference: 4433742 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 was reviewed: the batch is within the specifications and no discrepancy linked with this type of incident was observed.No other similar complaint was reported on the batch released in may 2019.Investigation results: despite requests, we did not receive the complaint sample nor x-ray pictures for evaluation.Conclusion; without the complaint sample or x-ray pictures, we cannot conclude on the real cause of this incident.Catheter rupture during the device explanation is a known complication of the access port implantation, documented in the ifu.This is a rare incident, no increasing trend is detectable in our complaint database.Consequently no corrective action is envisaged.

Event Description

Inability to safely extract the port catheter, the child was referred to a cardiac surgeon.

Event Description

Inability to safely extract the port catheter, the child was referred to a cardiac surgeon.

Manufacturer Narrative

Codes corrected: health effect: 3165.Device problem: 1528.

• Brand Name: CELSITE
• Type of Device: ACCESS PORT SYSTEM
• Manufacturer (Section D): B.BRAUN MEDICAL SAS; 26 rue armengaud; saint clou
• 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: 18111760
• MDR Text Key: 327879163
• Report Number: 9612452-2023-00021
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 04038653917587
• UDI-Public: 4038653917587
• Combination Product (y/n): N
• Reporter Country Code: HR
• 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,Followup
• Report Date: 11/17/2023

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 Operator: Health Professional
• Device Expiration Date: 05/02/2024
• Device Model Number: 4433742
• Device Lot Number: 36947922
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/11/2023
• Initial Date FDA Received: 11/10/2023
• Supplement Dates Manufacturer Received: 10/11/2023
• Supplement Dates FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2019
• 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): Required Intervention