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

Lot Number REFX1941

Device Problem Defective Device (2588)

Patient Problems Fever (1858); Pain (1994); Skin Inflammation/ Irritation (4545); Drug Resistant Bacterial Infection (4553)

Event Date 05/09/2022

Event Type  Injury  

Event Description

A bard powerport was placed in my left shoulder for chemo administration.On (b)(6) 2022, the nurse changed protocol and "pushed" instead of infused.I noticed something straight away.By the (b)(6), i was in the er with swelling and redness all around the port.It was feverish and very painful.I tried to get medical attention for the port for 7 continuous weeks to no avail.Finally my oncology nurse demanded it be removed after it had ruptured on its own and was draining puss and blood.It was removed in the er at bedside and i was put into the hospital for observation.On the 4 or 5 day, i tested positive for mssa.This was the second hospital stay due to this powerport,the first being 4 days, this one lasted 10 days.I left the hospital having to self administer antibiotics for the remainder of 28 days which was 19 days.When the power port was removed, i had my niece retrieve it from the trash and it was very clear to see 3 punctures and one crack in the product.I have since misplaced it but i also have several witnesses to what you that powerport looked like.I was very sick.My chemo had to be placed on hold for several weeks.Today, i am still not finished receiving treatment due to being put on hold for so many times and for so long each time.I have residual complications such as shortness of breath, weakness of extremities and as stated above i am still battling breast cancer which should have taken less than 9 months and here i am, close to a year and only barely halfway done.This powerport was defective.I only wish i was in a better state of mind to be able to hold onto that powerport.I should be able to sue bard for defective product.

• Brand Name: POWER PORT IMPLANTABLE PORT
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 16214818
• MDR Text Key: 307896744
• Report Number: MW5114397
• Device Sequence Number: 1
• Product Code: LKG
• 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: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/31/2023
• Device Lot Number: REFX1941
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 150 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White