MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. BARD POWER PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Health Effect - Clinical Codes	Distress (2329); Foreign Body In Patient (2687)
Date of Event	10/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Pt had removal of a bard port a cath (power port) on (b)(6) 2023 in the operating room.Pt experienced discomfort and a bump under the skin post procedure.Pt was seen by a different surgeon in the office on (b)(6) 2023 who removed a small clip fragment of the catheter under the incision site.The clip fragment was not sent to pathology upon removal so have no way of knowing if the retained item event was device related or practitioner related.Removal of the clip fragment occurred in the md office with local numbing medication and the pt returned home after the minor procedure.History of anal cancer and mass in the left chest wall.

• Brand Name: BARD POWER 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: 18086563
• Report Number: MW5147870
• Device Sequence Number: 17831174
• Product Code: LJT
• UDI-Device Identifier: 00801741026959
• UDI-Public: (01)00801741026959
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/06/2023
• 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: 59 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White