MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. PORT-A-CATH BARD POWER PORT DUO MRI; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	1829570
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	04/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Bard power port duo 9.5 f placed on (b)(6) 2021.On (b)(6) 2021 ct chest / abdomen done with contrast at another facility.Reported noted that there was extravasation in the port-a-cath.Pt presented to have port changed.This port is part of a urgent medical recall by bard access systems.

• Brand Name: PORT-A-CATH BARD POWER PORT DUO MRI
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 11752165
• Report Number: MW5101081
• Device Sequence Number: 4688899
• Product Code: LJT
• UDI-Device Identifier: 00801741027192
• UDI-Public: (01)00801741027192
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/27/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 1829570
• Device Catalogue Number: 1829570
• Device Lot Number: REEX0568
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 91