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

Model Number CP00003

Device Problems Difficult to Flush (1251); Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 06/13/2023

Event Type  malfunction  

Event Description

Patient arrived in outpatient clinic for chemotherapy infusion.Mediport was accessed and flushed without difficulty, although patient report slight pain with flushing.However, blood return was unable to be obtained.Patient underwent chest x-ray and venogram which revealed right chest port connected to a portion of the tubing that extends towards the internal jugular vein.The majority of the tubing is displaced distally rejecting over the expected location of the right atrium and ivc.Patient underwent removal of mediport, retrieval of catheter fragment, and insertion of a new mediport.

• Brand Name: POWERPORT ISP 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: 17216116
• MDR Text Key: 318026598
• Report Number: 17216116
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CP00003
• Device Catalogue Number: CP00003
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/16/2023
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19345 DA
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Race: White