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

Model Number 1829500

Device Problem Nonstandard Device (1420)

Patient Problem Insufficient Information (4580)

Event Date 06/01/2021

Event Type  malfunction  

Event Description

Device identified as a recalled product.Patient no longer required device for therapy, explanted.

• 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: 12031650
• MDR Text Key: 257188844
• Report Number: 12031650
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027185
• UDI-Public: (01)00801741027185(17)211231(10)REEU3083
• 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: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1829500
• Device Catalogue Number: 1829500
• Device Lot Number: REEU3083
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/02/2021
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1