MAUDE Adverse Event Report: ANGIODYNAMICS SMARTPORT

Catalog Number CT80STPD

Device Problem Use of Device Problem (1670)

Patient Problem Unspecified Infection (1930)

Event Date 09/09/2015

Event Type  Injury  

Event Description

On (b)(6) 2015 i had a procedure to install a port for receiving chemotherapy, the surgeon assisting nurse asked when i would be receiving my chemo, i told her it was scheduled for (b)(6) 2015 she stated the surgeon would leave a needle in the port for easy accessed the next day and at this time the attending nurse would dress the wound.Upon arrival at my doctors, i was informed i had an infection in my chest and neck, there was no needle installed simply a loose piece of gauze, they put me on antibiotics.I am in great deal of pain and can barely sleep.The surgeon was dr.(b)(6) at (b)(6).The port is by angiodynamics (b)(4), lot #4909405.

• Brand Name: SMARTPORT
• Type of Device: SMARTPORT
• Manufacturer (Section D): ANGIODYNAMICS
• MDR Report Key: 5080799
• MDR Text Key: 26004555
• Report Number: MW5056188
• Device Sequence Number: 1
• Product Code: FPA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Report Date: 09/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CT80STPD
• Device Lot Number: 4909405
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 81