MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWERPORT DUO M.R.I. IMPLANTABLE PORT; PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 5829502

Device Problem Material Rupture (1546)

Patient Problem Pain (1994)

Event Date 03/15/2021

Event Type  malfunction  

Event Description

Patient had double lumen bard powerport duo placed about two months ago.Port eventually became dysfunctional, with lateral lumen causing the patient pain with use.Port was removed last week, and on removal, it was evident the lateral lumen of the port had ruptured.Manufacturer response for bard 9.5 french polyurethane double lumen powerport duo port, duo powerport (per site reporter): no answer to date.

• Brand Name: POWERPORT DUO M.R.I. IMPLANTABLE 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: 11581009
• MDR Text Key: 242702467
• Report Number: 11581009
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5829502
• Device Catalogue Number: 5829502
• Device Lot Number: REEV2356
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/24/2021
• Device Age: 2 MO
• Event Location: Other
• Date Report to Manufacturer: 03/29/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20075 DA
• Patient Weight: 155