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

Model Number ST501L

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Pocket Erosion (2013)

Event Date 07/01/2015

Event Type  Injury  

Manufacturer Narrative

Batch history review: (b)(4) other similar incident was declared to us concerning this batch of access ports by the same hospital in (b)(6).The raw material certificates, the mfr'g and sterilization processes have been reviewed.No abnormality has been detected.Investigation: the involved device has been returned for evaluation.It presents no aspect defect.It is compliant w/the specifications.Conclusion: the collected info did not allow to conclude on the root cause of this incident.Our complaint handling database does not show any increasing trend for this type of complaint.It is rare incident.No corrective action is envisaged.It is worth nothing that the celsite t501l access port, reference (b)(4) is not cleared in the us, but this device is similar to the reference (b)(4) (k130576).

Event Description

Exteriorization of access port.

• Brand Name: CELSITE ACCESS PORT
• Type of Device: ACCESS PORT SYSTEM
• Manufacturer (Section D): B. BRAUN MEDICAL SAS; boulogne ; FR
• Manufacturer Contact: 30 avenue des temps modernes; chasseneuil, cedex 83361
• MDR Report Key: 5091428
• MDR Text Key: 26373771
• Report Number: 9612452-2015-00020
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: 130576
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Not Applicable
• Remedial Action: Other
• Report Date: 09/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: ST501L
• Device Catalogue Number: 4437022
• Device Lot Number: 36890289
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/28/2015
• Date Manufacturer Received: 08/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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