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

Model Number 4433742

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Extravasation (1842)

Event Date 02/06/2023

Event Type  Injury  

Event Description

"surgical intervention due to dysfunctional catheter with 1 year of use.Removal of implantable catheter due to surgical intervention and report of quality failure to technovigilance.".

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 (b)(4).Batch history review: we have checked the manufacturing file of batch nr 36982260 which complies with our specifications and does not present any discrepancy.No other similar complaint has been reported on this batch of access ports released in august 2021.Investigation results: we did not receive the complaint sample for evaluation.The x-ray picture received is inconclusive.Conclusion: without the complaint sample,we cannot conclude on the real cause of this incident.This is a rare incident, no corrective action is envisaged for the moment.

Event Description

"surgical intervention due to dysfunctional catheter with 1 year of use.Removal of implantable catheter due to surgical intervention and report of quality failure to technovigilance.".

Manufacturer Narrative

Device history record: the batch record, number 36982260 was reviewed: the batch is within the specifications and no discrepancy was observed.No other similar complaint was reported on the units released in august 2021.Summary of investigation: the device was implanted for 1 year.One celsite babyport set pur device, from batch 36982260, was returned for investigation.- visual inspection of the returned device: -> access port housing: some blood traces are observed.Around 5 puncture marks are detected inside the silicone septum.No defect is visually present.-> connection ring: the connection ring is still thread on the catheter and connected to the access port housing.No visible defects are detected.-> catheter: some coagulated blood is present inside the catheter.The catheter, of around 9.5 cm long, is still connected to the access port housing.4 longitudinal diametrically opposite cracks, between 2 to 7 mm long, are detected at the graduation level 5.In this area the catheter is also flattened.This proves that the catheter was pinched at this level, leading to these cracks.- dimensional measures: the inner and outer diameters of the returned catheter are measured and are compliant with the defined specifications.- x-ray picture review: the date of the x-ray picture is not visible, so it was impossible to determine whether it was the x-ray taken during device implantation or not.The catheter, of around 10 cm long, is implanted via the subclavian route onto a 3-year-old patient.Root cause: base on the observation performed on the returned catheter and on the x-ray picture, the root cause is confirmed: the catheter was crushed in the costo-clavicular space and repeated squeezing has led to the cracks of the catheter: it is the pinch-off syndrome.Conclusion: the complaint is not confirmed.Indeed, the cracks of the catheter was due to the fact that the catheter was crushed in the costo-clavicular space and repeated squeezing has led to the rupture of the catheter.This is the pinch-off syndrome.The instructions for use warn the physicians against the risk entailed by placing via the subclavian route.The incident is not imputable to the device; no actions plan is foreseen at that time.

• 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: 16774471
• MDR Text Key: 313630437
• Report Number: 9612452-2023-00005
• 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,Followup
• Report Date: 07/24/2023

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: 4433742
• Device Lot Number: 36982260
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/21/2023
• Initial Date FDA Received: 04/20/2023
• Supplement Dates Manufacturer Received: 03/21/2023
• Supplement Dates FDA Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2021
• 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
• Patient Age: 3 YR
• Patient Sex: Male