MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. BARDPORT, SLIMPORT, X-PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Device Problems Flushing Problem (1252); Use of Device Problem (1670); Fail-Safe Problem (2936)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2023

Event Type  Injury  

Event Description

Literature review and mifus included in this line corporate supply chain to escalate an issue brought to us by our clinical leaders, risk management, and regulatory.Specifically, they are looking to escalate the issue that your mifu indicates that heparin flushes be used to maintain the port patency.The clinical leadership have reviewed the literature on best practice coming out of oncology nursing society and ins nursing societies and would like to follow the recommendation of removing heparin from the port line flushes.Proposed change: current practice - to flush with saline then heparin for all non-valved ports.Proposed practice change - to flush with only normal saline in a pulsatile method.The issue requiring your assistance: the issue is that the ins and ons guidelines to no longer use heparin when flushing implanted ports does not match the mifus.A different manufacturer, angiodynamics, offers optionality between heparin or saline for maintaining patency.Next steps: we would need the mifu updated in order to execute this change and standardize practice across our health system.This has been cleared with nursing shared governance, smilow oncology nursing leadership, non-oncology nursing leadership (neurosciences, hoit, interventional immunology), pharmacy, and the education consortium.There are concerns for patient safety if we stay with the current practice, as well as a significant cost savings associated with the practice change.I have included the literature cited by the teams proposing this change for your reference below as well as all mifus including the angiodynamics one that offers optionality.Manufacturer response for port access devices, conversation started with bard, they are discussing internally.The rep said this is new information they have been working on, but may offer product alternative rather than changing the mifu to reflect the latest research.Rep is working on putting together a call with bard medical and our ynhhs stakeholders.

• Brand Name: BARDPORT, SLIMPORT, X-PORT
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 16681522
• MDR Text Key: 312695249
• Report Number: 16681522
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/22/2023

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/22/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/05/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/05/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1