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

Model Number REF-CP00003

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 03/20/2019

Event Type  malfunction  

Event Description

Pt came to our hosp for replacement of a malfunctioning venous access port placed by (b)(6) clinic.Initial imaging revealed the port catheter had separated from the port hub and entered into the pt's pulmonary artery.The catheter was surgically removed.

• Brand Name: BARD POWER PORT CATHETER PORT
• Type of Device: PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRANVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS INC.
• MDR Report Key: 8470290
• MDR Text Key: 140587162
• Report Number: MW5085396
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/26/2019

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 Operator: Health Professional
• Device Model Number: REF-CP00003
• Device Lot Number: REZH1386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/29/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR