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 02/11/2020

Event Type  No Answer Provided  

Event Description

Angiodynamics power port placed on (b)(6) 2019.Pt came for blood draw today and this is the 3rd time in a row pt had difficulty getting blood for labs from port.Requires several flushes and pt in supine position with left arm elevated.Blood return for lab was finally attained.Port placed (b)(6) 2019 w/o problems.Cxr shows tip svc/ra jct.The 'ct' stamp on port to indicate pressure injection is barely visible, could see when i used magnifier in epic imaging.Very unusual to have problems with blood return / lab collection and ns flush.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: 9739679
• MDR Text Key: 180853308
• Report Number: MW5093174
• 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: 5528062
• 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: 48 YR