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

Model Number 5829502

Device Problems Nonstandard Device (1420); Material Rupture (1546); Material Protrusion/Extrusion (2979)

Patient Problem Pain (1994)

Event Date 03/08/2021

Event Type  malfunction  

Event Description

Left ij dl bard duo powerport placed a month a half ago.During mri, three weeks ago, had likely extravasation as she felt pain with contrast injection.Mri done at outside facility.A nuclear flow study performed the same day showed extravasation.Port removed a week later.Medial lumen found to be partially extruding/ruptures.It was replaced with another bard powerport duo as it was most appropriate port for this patient.Last week, bard released recall notice for this and other lots of this power port.Manufacturer response for power port, bard 9.5 french double lumen powerport duo port (per site reporter): no information to date.This lot was subject of a recall.

• 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: 11618919
• MDR Text Key: 243987793
• Report Number: 11618919
• 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: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/01/2021
• Device Age: 2 MO
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 04/06/2021
• 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: 15695 DA
• Patient Weight: 108