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

Patient Problems Distress (2329); Foreign Body In Patient (2687)

Event Date 10/05/2023

Event Type  Injury  

Event 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
• 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: 18086563
• MDR Text Key: 327631271
• Report Number: MW5147870
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026959
• UDI-Public: (01)00801741026959
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White