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

Model Number 4433750

Device Problems Detachment Of Device Component (1104); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/12/2018

Event Type  Injury  

Manufacturer Narrative

Note: product reference (b)(4) is not cleared for sales in the usa, but its catheter is similar to the product reference (b)(4) cleared under #510k 130576.Batch history review: the manufacturing file was reviewed.It is compliant with our specifications and no abnormality was detected.No other similar complaint was reported on this batch of access ports.Investigation results: the access port involved in this incident was not returned for evaluation.No through investigation is possible.Conclusion: the incident was discovered only 3 months after the implantation.No other incident was reported on the access ports batch.This information allows us to deduce that the catheter disconnection is probably due to incorrect catheter/port connection by the practitioner.The ifu's specify how to connect the catheter to the access port and the risks of incorrect connection.Note: due to it difficulties, encountered following the implementation of the new version of esubmittev3, this medwatch report was previously sent to the fda via dhl on (b)(6) 2018.

Event Description

Access port implanted in (b)(6) 2018.On (b)(6) 2018, catheter disconnection noted with a migration of the catheter tip to the sub-hepatic vein.

Manufacturer Narrative

Investigation results: we received for investigation one st305 access port from batch 36920260 with its connection ring and 2 pieces of catheter.No defect is visible on the access port housing.The catheter is cut into 2 pieces near graduation 10.The 1st part is 3.5cm long.The 2nd part is 5.8cm long.The extremity near graduation 15 is cut slanted and its slight distortion at this level allows us to say that this extremity was mounted onto the exit cannula.Dimensional measures: we have measured the returned device in order to check its conformity to our specifications.The following measures are in mm.All the characteristics conform to our specifications.Disconnection test: a disconnection test has been performed on the returned access port.The disconnection force obtained is 3 times superior to the requirement of the iso 10555-6.Conclusion: no manufacturing defect has been detected on the returned sample, the returned device is compliant with our specifications; the batch history file does not present any abnormality; the pull test at the juncture access port-catheter results conform to the requirements of nf iso 10555-6 standard.Implantable access ports - intravenous, intra-arterial, intra-peritoneal, intrathecal and epidural access ports.The disconnection forces of the catheter are more than 3 times superior to the requirement.The disconnection of the catheter is most probably due to the fact that the extremity of the catheter connected to the access port housing was cut slanted.In fact, if the catheter is not cut at right angle, the catheter does not completely surround the exit cannula until it touches the housing, which leads to a weaker connection force.The ifu specify to " cut the excess catheter (at right-angles) prior to connecting to the port."(ifu § vi-1-1-g).Slide the connection ring over the catheter, firmly push the catheter onto the exit cannula ensuring the catheter covers the length of the exit cannula, slide the connection ring over the catheter and exit cannula.The connection ring should be in contact with the port"."(ifu § vi-1-1-h) this is a rare incident ((b)(4)), no corrective action is envisaged at the moment.

• Brand Name: CELSITE
• Type of Device: ACCESS PORT SYSTEM
• Manufacturer (Section D): B.BRAUN MEDICAL SAS; 204 avenue du marechal juin; boulogne, 92100 ; FR 92100
• MDR Report Key: 7608851
• MDR Text Key: 111302995
• Report Number: 9612452-2018-00023
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2022
• Device Model Number: 4433750
• Device Lot Number: 36920260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2.5 YR
• Patient Weight: 12