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

Catalog Number	4433556
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Skin Inflammation (2443)
Date of Event	04/30/2016
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 complaint was reported on this batch of access ports.Investigation: the involved device was returned for evaluation.It has been measured.All the dimensions complied to the specifications.The catheter is not deteriorated.The material surface is smooth.No visible defect is detected.Photographic examination: a picture showed the skin inflammatory reaction was sent.This picture show that the skin over the trajectory of the tunneled catheter is reddish.The scar of the access port implantation is red too.Conclusion: the returned device is compliant with the specifications.No failure has been detected.The skin reaction observed after administration of 6 treatments cannot be explained with the elements in our possession.It is an isolated incident.No corrective action is envisaged.
Event or Problem Description
Access port implanted on (b)(6) 2015.After 6 treatments of taotere (100mg/m2), apparition of a skin redness on the whole length of the tunneled catheter.Blood culture: negative.No inflammatory reaction above the access port housing.

• Brand Name: CELSITE
• 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: 5675146
• Report Number: 9612452-2016-00020
• Device Sequence Number: 18940372
• Product Code: LJT
• UDI-Device Identifier: 04046963594916
• UDI-Public: 04046963594916
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K130576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 05/23/2016

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: No Information
• Device Expiration Date: 08/17/2020
• Device Catalogue Number: 4433556
• Device Lot Number: 36900344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2016
• Initial Report FDA Received Date: 05/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention