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

Catalog Number 1808001

Patient Problems Chest Pain (1776); Dyspnea (1816); Fatigue (1849); High Blood Pressure/ Hypertension (1908); Increased Respiratory Rate (2486); Cough (4457); Wheezing (4463)

Event Date 10/12/2023

Event Type  Injury  

Event Description

Pt had shortness of breath, wheezing, coughing, weakness, high blood pressure, went to er, ct scans done just diagnosed copd exacerbation.Pt remained sick for a month and a half despite treatment, chest pain, tachypnea, wheezing, suspected pe due to history.

• Brand Name: BARD POWER PORT MRI IMPLANTABLE PORT
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 18205095
• MDR Text Key: 329136166
• Report Number: MW5148480
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/20/2023

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 Catalogue Number: 1808001
• Device Lot Number: REGW 1911
• 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): Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 39 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White