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

Model Number	4808560
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During insertion of power port, the surgeon noted a hole in the catheter of the power port.Device immediately explanted and a new one implanted.Anesthesia started 1321 and anesthesia stopped 1433.Initially the access of the (l) subclavian vein was unsuccessful then turning to access of the left internal jugular with ultrasound guidance.After second power port placement confirmed w/fluoroscopy w/excellent forward and backflush.Patient to pacu in stable condition as they tolerated procedure without any complications or concerns.

• Brand Name: POWERPORT M.R.I., GROSHONG
• 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: 20236272
• Report Number: 20236272
• Device Sequence Number: 12950453
• Product Code: LJT
• UDI-Device Identifier: 00801741027345
• UDI-Public: (01)00801741027345
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/28/2024
• Report Date (Section F): 05/28/2024

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: 4808560
• Device Catalogue Number: 4808560
• Device Lot Number: REJN0012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 09/17/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2024
• 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
• Patient Age: 2 MO
• Patient Sex: Female
• Patient Weight: 89 KG
• Date Report Sent to FDA: 05/28/2024