MAUDE Adverse Event Report: NAVILYST MEDICAL NAVILYST MEDICAL, BIOFLO; PORT, INTERNAL, SUBCUTANEOUS

Catalog Number H965450170

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Unspecified Infection (1930)

Event Date 09/07/2014

Event Type  Injury  

Event Description

As reported, pt with colon cancer and copd was implanted in their right chest with a bioflo port for chemotherapy on (b)(6) 2014 and developed a post-operative infection.The port was removed on (b)(6) 2014.The used port was discarded at the hospital.

Manufacturer Narrative

Review of the device history records for the reported port packaging tray lot shows that the tray sealing parameters documented for temperature, time and pressure were correct per navilyst medical procedures.In addition, seal check (visual) and tray burst testing was performed on both the inner and outer trays.This tray testing was performed pre-production and post-production there were no out of specification conditions; all testing passed.No non-conformances were written against the reported packaging lot related to port tray seal issues.In additional there have been no non-conformances written against the port assembly lots or catheter tubing component lot for any issues that would contribute to a failure mode of patient infection.Sterilization records were reviewed for the port packaging lot and there were no non-conformances reported for this sterile load.The 07/2014 navilyst medical complaint report was reviewed for the bioflo port product family for the failure mode "patient injury - infection." no adverse trends were identified.The root cause of the pt infection is unable to be determined, and there is no evidence that the manufacturing, packaging, or sterilization of the bioflo port contributed to the event.Potential contributing factors for patient infections include the port placement procedures and device care and maintenance.The directions for use packaged with the device cautions that the integrity of the device packaging should be examined before use.((b)(4)).

• Brand Name: NAVILYST MEDICAL, BIOFLO
• Type of Device: PORT, INTERNAL, SUBCUTANEOUS
• Manufacturer (Section D): NAVILYST MEDICAL; glens falls NY
• Manufacturer (Section G): NAVILYST MEDICAL; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: michael duerr ; 10 glens falls technical park; glens falls, NY 12801 ; 5187424571
• MDR Report Key: 4170358
• MDR Text Key: 21525654
• Report Number: 1317056-2014-00059
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131694
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2015
• Device Catalogue Number: H965450170
• Device Lot Number: 4688883D
• Other Device ID Number: BIOFLO PORT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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
• Patient Age: 57 YR