MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORT-A-CATH; PORT AND CATHETER IMPLANTED SUBCUTANEOUS INTRAVASCULAR

Model Number 5207-24A

Device Problem Fluid/Blood Leak (1250)

Patient Problems Scarring (2061); Skin Discoloration (2074); Swelling (2091); Deformity/ Disfigurement (2360)

Event Date 10/14/2019

Event Type  Injury  

Event Description

On (b)(6) 2019 received 1st infusion for chemotherapy.Later that evening noticed leakage of fluid coming from port site out of concern i admitted myself to (b)(6) er for further evaluation.It was determined at that time that there was a malfunction with the device itself.After the er temporarily stopped the leakage, the following morning i returned to (b)(6) hosp to report the incident.The leakage was still occurring but the medical team continued to proceed with infusion.On the third day, the leakage was still prevent and it was determined that there was an issue with the port, as well as, swelling and discoloration at the port site and my upper left arm and chest area.On (b)(6) 2019, port was removed from left chest arm and sent to pathology for evaluation and testing.New port was implanted in right arm.As a result of the action i am subjected to having to take xarelto (a blood thinner) for the duration of my lifetime to prevent any blood clotting that can be fatal besides my initial condition of gastric cancer, also permanent scar where port was removed from left chest area, (disfigurement).

• Brand Name: PORT-A-CATH
• Type of Device: PORT AND CATHETER IMPLANTED SUBCUTANEOUS INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC. ; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9504018
• MDR Text Key: 172615605
• Report Number: MW5091781
• 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: Patient
• Type of Report: Initial
• Report Date: 12/04/2019
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 5207-24A
• Device Catalogue Number: 21-4483-24
• Device Lot Number: 3826325
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 58