MAUDE Adverse Event Report: ANGIODYNAMICS SMART PORT; PORT AND CATHETER, IMPLANTED SUBCUTANEOUS, INTRAVASCULAR

Model Number H787CT80STPDV11

Device Problem Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/03/2020

Event Type  No Answer Provided  

Event Description

Ongoing difficulty obtaining blood return on smart port inserted (b)(6) 2020.At daily appts (b)(6) and again at appt on (b)(6) 2020 difficulty obtaining blood return.Able to obtain blood return each day after saline flushing and pt repositioning multiple times.Unable to obtain consistent blood return for lab draw on (b)(6) 2020 until after iv infusion.Fda safety report id# (b)(4).

• Brand Name: SMART PORT
• Type of Device: PORT AND CATHETER, IMPLANTED SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ANGIODYNAMICS
• MDR Report Key: 9739664
• MDR Text Key: 180826795
• Report Number: MW5093173
• 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: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H787CT80STPDV11
• Device Lot Number: 5532259
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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 Age: 27 YR