MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWERPORT CLEARVUE SLIM IMPLANTABLE PORT SLIM MR 8F - LOG15341; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number LOG1534175

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 04/14/2023

Event Type  Injury  

Event Description

Port placed on (b)(6) 2023 and post-procedure xray showed right-sided power-injectable single-lumen tunneled chest port, with catheter tip in the expected location of the cavoatrial junction.Access of the port was attempted on (b)(6) 2023 and was unsuccessful; port was able to be flushed but no blood return.Chest xray on (b)(6) 2023 showed the right chest infusion port was displaced with its tip noted about the right lower neck.Port was removed and replaced on (b)(6) 2023.

• Brand Name: POWERPORT CLEARVUE SLIM IMPLANTABLE PORT SLIM MR 8F - LOG15341
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 16789485
• MDR Text Key: 313826992
• Report Number: MW5116889
• Device Sequence Number: 1
• Product Code: LJT
• 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: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LOG1534175
• Device Catalogue Number: 1618000
• Device Lot Number: REGZ2577
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 116 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White