MAUDE Adverse Event Report: BARD ACCESS SYSTEM INC. POWERPORT DUO MRI IMPLANTABLE PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 5829502

Device Problems Obstruction of Flow (2423); Noise, Audible (3273)

Patient Problem Infiltration into Tissue (1931)

Event Date 02/08/2021

Event Type  malfunction  

Event Description

Patient had a bard powerport duo mri implantable port that was inserted on (b)(6) 2021.While getting a ct it was noted that the contrast was not flowing and then a "pop" was heard.The site was then noted to be infiltrated.One side of the double lumen port was disrupted.Fda safety report id# (b)(4).

• Brand Name: POWERPORT DUO MRI IMPLANTABLE PORT
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEM INC. ; salt lake city UT 84116
• MDR Report Key: 11343087
• MDR Text Key: 232826657
• Report Number: MW5099450
• Device Sequence Number: 1
• Product Code: LJT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/12/2021

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: Health Professional
• Device Model Number: 5829502
• Device Catalogue Number: 5829502
• Device Lot Number: REEV2356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/17/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR