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

Catalog Number	4433742
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091)
Date of Event	06/27/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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: despite requests, nor the involved device nor the x-rays pictures were returned for analysis.No thorough investigation can be performed at this time.Conclusion: no conclusion can be drawn.The complaint handling database does not show any increasing trend for this type of access port.No corrective action is envisaged.
Event or Problem Description
On (b)(6) 2014, implantation of an access port via right subclavian approach.On (b)(6) 2016, during the checking before the chemotherapy injection, it was detected pain at the right shoulder and oedema at the upper part of the access port.On (b)(6) 2016, the patient was taken to operating theater for access port removal because of dysfunction suspiciaon.The removed catheter displays a crack on its thrid proximal part, at about 5 mm from the connection.No defect is apparent on the rest of the catheter.
Additional Manufacturer Narrative
Investigation results: we received for investigation one celsite babyport access port from batch (b)(4).The 12.7 cm long catheter is still connected the access port housing with the connection ring.There are a lot of blood residues around the catheter.The catheter is cracked at 2.6 cm of the port housing.As the catheter is slacked around the crack, this means that the crack is due to catheter burst at this level.This means that a high pressure was applied in the system.Indeed it is worth noting that, according to our specifications, this type of catheter is designed to resist to a minimum pressure of 10 bars.This high pressure can be applied in an access port only if the device is obstructed.Conclusion: the evaluation of the explanted device did not allowed us to detect any manufacturing defect on the device.The catheter burst observed probably results from the fact that excessive pressure has been applied during the injection while the catheter was obstructed by an external element (drug crystallisation, thrombus, fibrin sleeve,.).The ifu specify to always verify that the port is functional by aspirating blood then injecting nacl before attempting to start an infusion and give some advices to avoid occlusion of the system and to avoid generating excessive pressures in case of occlusion of the system.It is an isolated case.No manufacturing defect has been detected on the returned sample, consequently no corrective action is envisaged.

• Brand Name: CELSITE BABYPORT
• Common Device Name: ACCESS PORT SYSTEM
• Manufacturer (Section D): B.BRAUN MEDICAL SAS - OWNER; 204 avenue du marechal juin; boulogne billancourt, ile de france 92100 ; FR 92100
• MDR Report Key: 5856998
• Report Number: 9612452-2016-00030
• Device Sequence Number: 18949101
• Product Code: LJT
• UDI-Device Identifier: 04046963594947
• UDI-Public: 04046963594947
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: K130576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2016

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
• Operator of Device: Physician
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 4433742
• Device Lot Number: N020830T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2016
• Supplement Report FDA Received Date: 09/28/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 2 YR