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

Model Number 4433876

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Discomfort (2330)

Event Type  malfunction  

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.Device history record the batch record filr, number 36979783 was reviewed: the batch was manufactured within the specifications and no discrepancy was observed.No other similar complaint was reported on the batch released in may 2021.Summary of investigation no sample, no picture, no x-ray picture, no information were returned for investigation.Raw material historical review: the batch records of the catheters, of the connection rings and of the access ports housing included into the impacted device kit were verified.Those are compliant with the defined specifications and no discrepancy was observed.All raw materials used for the manufacturing of those elements were compliant at receipt too.No other similar complaint was reported for those elements and raw materials.Manufacturing process review: visual inspections and dimensional controls are performed during our manufacturing process.Nothing in our manufacturing process could explain the observed defect.Root cause without the complaint sample or x-ray pictures for investigation, no thorough investigation is possible and we cannot conclude on the real cause of the incident.Ifu recommendations: the ifu specifies the connection method to well connect the catheter and the access port housing with the connection ring: "the catheter should be mounted on the exit cannula along its axis (see fig.11 a-b-c, page 115) and not across the axis and should be completely mounted on the exit cannula before the connection ring is slid over the catheter." conclusion without the sample and x-ray pictures for evaluation, it is not possible to determine the root cause of the catheter disconnection.However, it is worth noting that the batch history record has not actually revealed failure during manufacturing process and that no other similar complaint was reported on this access port batch.This is an isolated event.In the future, if this incident occurs again, please retain the sample so that a complete investigation can be performed.If a sample do become available, the complaint will be reopened for further evaluation.Catheter disconnection is a known complication for which the complaint rate remains low (b)(4).No corrective action is currently envisaged as ifu already gives recommendation.

Event Description

"customer information (b)(6).Dr (b)(6), who fitted her with the implant, took her out of the access port after she went to emergency because she was feeling very unwell.The implant had a "loose connection".

• 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: 18541515
• MDR Text Key: 333196780
• Report Number: 9612452-2024-00002
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4433876
• Device Lot Number: 36979783
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2021
• 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