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

Model Number 4437027

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Death (1802); Post Operative Wound Infection (2446)

Event Date 02/17/2019

Event Type  Death  

Manufacturer Narrative

We are currently trying to obtain more information about this incident, especially the batch number of the device in order to perform a review of the manufacturing records.The review of the customer complaints database does not show any increasing trend for infection following access port implantation.The global complaint rate for infection on celsite access ports is very low: (b)(4).

Event Description

Infection detected 48hours after the implantation of the access port.Streptococcus a detected.Patient dead 4 days after, due to multi visceral failures.

Manufacturer Narrative

Note : product reference:(b)(4) is not cleared for sales in the usa, but similar product reference: (b)(4) is cleared under #: 510k130576.Batch history review: we have checked the manufacturing file of batch nr 36942215 which complies with our specifications and do not present any discrepancy.The sterilization records, the lal and bioburden test results were reviewed.All data are compliant with our requirements.No other similar complaint has been reported to us on this batch of 249 access ports released in january 2019.Investigation: we did not received the complaint sample for investigation.The information provided mentioned that the streptococcus a bacteria was at the origin of the infection.This bacteria is naturally present on the skin.We perform periodic bioburden tests on our non-sterile products (before sterilization) and identification of the viables.Streptococcus a has never been identified in our products during our routine inspections.Conclusion: the received elements do not allow us to conclude on the real cause of the infection.Our records show that these batches of celsite access ports have been manufactured, packed and sterilized in compliance with our specifications.The review of the customer complaints database does not show any increasing trend for infection following access port implantation.The global complaint rate for infection on celsite access ports is (b)(4).No corrective action is envisaged.

Event Description

Implantation of the access port on (b)(6) 2019.On (b)(6) 2019: fever and acute renal insufficiency.On (b)(6) 2019: multi-visceral deficiencies.Patient's death.Streptococcus a.

• Brand Name: CELSITE
• Type of Device: ACCESS PORT SYSTEM
• Manufacturer (Section D): B.BRAUN MEDICAL SAS; 26 rue armengaud; saint cloud, 92210 ; FR 92210
• MDR Report Key: 8782537
• MDR Text Key: 150805964
• Report Number: 9612452-2019-00081
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 08/13/2019

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?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/02/2024
• Device Model Number: 4437027
• Device Lot Number: 36942215
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/19/2019
• Initial Date FDA Received: 07/11/2019
• Supplement Dates Manufacturer Received: 06/19/2019
• Supplement Dates FDA Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death