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

Model Number	1806061
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	12/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Powerport placed several months ago.Tissue around his port was swelling with injections.There was a hole in the back side of the port.I can¿t say when this happened, but it was likely due to an access attempt.Port replaced.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE PORT
• Common Device Name: PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 19285542
• Report Number: 19285542
• Device Sequence Number: 12880180
• Product Code: LJT
• UDI-Device Identifier: 00801741026959
• UDI-Public: (01)00801741026959
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/11/2024
• Report Date (Section F): 01/11/2024

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 Model Number: 1806061
• Device Catalogue Number: 1806061
• Device Lot Number: REHQ0333
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/10/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/11/2024