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

Model Number CP00003

Device Problems Fluid/Blood Leak (1250); Fracture (1260); No Flow (2991)

Patient Problems Failure of Implant (1924); Pain (1994); Swelling/ Edema (4577)

Event Date 05/26/2023

Event Type  malfunction  

Event Description

Patient arrived for treatment.Mediport was accessed, however blood return was unable to be obtained.Upon flushing the catheter, swelling was noted an inch above the port site.Patient noted pain with flush.Chest x-ray revealed right-sided central venous port catheter with fractured catheter tubing.Patient underwent extraction of port and retrieval of catheter tubing and placement of new port.

• 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: 17216052
• MDR Text Key: 318026723
• Report Number: 17216052
• 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
• Device Lot Number: RECQ0322
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/16/2023
• Device Age: 5 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: 24090 DA
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Race: White