MAUDE Adverse Event Report: PORT A CATH

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Swelling (2091)

Event Date 09/05/2017

Event Type  Injury  

Event Description

Mediport accessed and rn started to flush when she noticed an area of swelling during the flush.Rn stopped and notified dr (b)(6).Pt sent straight to interventional radiology.Diagnosis or reason for use: chemotherapy, iv access.

• Brand Name: PORT A CATH
• Type of Device: PORT A CATH
• MDR Report Key: 7048551
• MDR Text Key: 92652087
• Report Number: MW5073453
• 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: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR