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

Model Number 1808000

Patient Problems Failure of Implant (1924); Pain (1994); Thrombosis/Thrombus (4440); Cough (4457); Swelling/ Edema (4577)

Event Date 10/27/2023

Event Type  Injury  

Event Description

Patient had pain and swelling in extremity (upper left ca) and evaluated at (b)(6) hospital.Hospitalized and evaluated further, blood clot confirmed.Blood thinner prescribed and port just removed on (b)(6) 2023.October 2023 was evaluation and hospitalization.Face also swollen at the time, cough present as well.

• Brand Name: POWERPORT M.R.I. IMPLANTABLE PORT
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 18205081
• MDR Text Key: 329126349
• Report Number: MW5148476
• 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: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1808000
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/22/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White