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

Model Number 4433750

Device Problem Material Rupture (1546)

Patient Problems Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)

Event Date 10/23/2018

Event Type  Injury  

Manufacturer Narrative

Note : product reference 4433750 is not cleared for sales in the usa, but it is similar to the product reference celsite 5433750.Cleared under #510k130576.Batch history review: we have checked the manufacturing file of batch nr36935521 of celsite access ports which complies with our specifications and does not present any discrepancy.No other complaint has been reported to us on this batch of (b)(4) access ports released in august 2018.Investigation results: we received for investigation one celsite st305 access port from batch nr36935521, we have noticed 2 punctures on the septum.We received 2 parts of catheter.1 part of 11.4cm long connected to the access port, it is graduated from 14 to 24.Its rupture area is grainy.The other part of the received catheter measures 13.3cm long graduated from 5 to 13.The rupture area has a smooth part and a rough part.Despite the difference between the rupture areas of both catheter parts, they fit perfectly.We received the connection ring connected to the access port, no defect has been detected.Dimensional measures: we have measured the returned device in order to check its conformity to our specifications: characteristics, measures (mm), specifications (mm): catheter: int.Diameter, 1.04, 1.05+/-0.05.Ext.Diameter, 2.18, 2.20+/-0.05.These characteristics conform to our specifications.We received x-ray pictures showing the implantation via the jugular vein.At the entrance of the jugular vein, we can see that the catheter was kinked because of the very small angle at this level.The x-ray pictures extrapolation shows that the noticed rupture on the returned sample has been occurred at the entrance of the jugular vein, at the kinking level.We also noticed that the catheter was short, the distal extremity was not at the right auricle entrance.Conclusion: no manufacturing defect has been detected on the returned sample; the returned sample is compliant with our specifications.The noticed difficulties regarding the blood flow return could be explained by the shortness of the catheter and the kink noticed at the entrance of the jugular vein.According to the nature of both ruptured areas, especially to the smooth part, we think that the rupture has been initiated during the implantation.According to the received elements and the investigation results, we can conclude that the root cause of this incident is not related to the device.It is worth noting that the ifu specifies, "during the implantation ensure that the catheter is not damaged by unguarded forceps, suture needle or other sharp instruments" (ifu, § vi).This is a rare incident.No corrective action is envisaged.B braun (b)(4) has provided all the information currently available to us.

Event Description

Catheter rupture and migration: the device has been implanted on (b)(6) 2018 via the jugular vein.Some difficulties have been noticed the day after implantation as flushing the device and getting blood backflow.Patient has felt pain when the port is flushed, had difficulties to "breath" and to get rest in the evening.X ray pictures has been performed.A catheter rupture at the entrance of the jugular vein and migration of the distal part "have" been detected, "than" the entire device has been explanted by surgery.

• Brand Name: CELSITE
• Type of Device: ACCESS PORT SYSTEM
• Manufacturer (Section D): B.BRAUN MEDICAL; 26 rue armengaud; saint cloud 92210 ; FR 92210
• Manufacturer (Section G): B.BRAUN MEDICAL; 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: 8185253
• MDR Text Key: 131048123
• Report Number: 9612452-2018-00049
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/18/2023
• Device Model Number: 4433750
• Device Lot Number: 36935521
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2018
• 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: 18 YR
• Patient Weight: 80