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

Model Number 4436946

Device Problem Fracture (1260)

Patient Problems Inflammation (1932); Skin Erosion (2075)

Event Type  Injury  

Event Description

When the patient was implanted into the infusion port for the second course of treatment, the breast skin on the side of the infusion port was red and swollen, and then ulcerated.After eliminating various reasons, the port seat was removed, and the catheter was found to be broken during the removal process.

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 nr36982667 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 august 2021.Investigation results: we received for investigation one celsite st305p access port from batch nr36982667 with two segments of catheter.The proximal catheter segment is still connected to the access port.Visual examination: the device is contaminated by blood.A dozen of puncture marks are visible inside the silicone septum.At the level of the rupture, the two pieces of catheter do not match together.Part of the catheter seems not to have been returned for expertise.The proximal part measures 1.6cm.The second segment measures 13.2 cm, which is the distal part of the catheter presents two holes, voluntary done by the user, probably to obtain a multiperforated catheter.We have observed the ruptured extremities under binocular magnifier.The rupture facies is partially cut clear and shiny, this mean that this part was damaged by a sharp object.Outside this small cut, the fracture facies shows an irregular and rough aspect; this means that the material was torn at this level, leading to the complete fracture.Around the rupture we can observed several tools marks.Dimensional measures: we have measured the returned device in order to check its conformity to our specifications.All the measures conform to our specifications.Conclusion: according to the above-mentioned elements, seems to be due to a small damage done by a sharp object during the implantation procedure (scalpel, forceps.).This damage has then extended until the complete rupture of the catheter due to patient's movements.Catheter rupture is a known potential complication of the access port implantation.The ifu specify " during implantation ensure that the catheter is not damaged by unguarded forceps, suture needle or other sharp instruments".This is a rare incident (<0,001%) not imputable to the device, no corrective action is envisaged.

• 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: 15425561
• MDR Text Key: 299929570
• Report Number: 9612452-2022-00044
• 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
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2022

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 Operator: Health Professional
• Device Model Number: 4436946
• Device Lot Number: 36982667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2022
• Initial Date Manufacturer Received: 08/16/2022
• Initial Date FDA Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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