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

Model Number 1808560

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Neck Pain (2433); Swelling/ Edema (4577)

Event Date 03/31/2021

Event Type  malfunction  

Event Description

Port placed two years ago.Patient presented to gen surg with c/o neck pain and swelling with port flush.Port removed this year.Catheter removed in its entirety along with the port.At midpoint of catheter, there was a partial disruption including 50% of the circumference of the catheter.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE 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: 12293311
• MDR Text Key: 265581933
• Report Number: 12293311
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/03/2021

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: No Information
• Device Model Number: 1808560
• Device Catalogue Number: 1808560
• Device Lot Number: REDP2252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/03/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/09/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24820 DA