MAUDE Adverse Event Report: ANGIODYNAMICS, INC. NAMIC SQUEEZE CONTRAST CONTROLLER; SYSTEM, X-RAY, ANGIOGRAPHIC

Device Problem Use of Device Problem (1670)

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

Event Date 08/24/2018

Event Type  malfunction  

Event Description

When reviewing the instructions for use for the namic squeeze contrast controller, our infection preventionist noted that the instructions stated that the product can be used on multiple patients which we think goes directly against the joint commission safe medication practices.

• Brand Name: NAMIC SQUEEZE CONTRAST CONTROLLER
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): ANGIODYNAMICS, INC.; navilyst medical, inc.; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8974882
• MDR Text Key: 156939503
• Report Number: 8974882
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/07/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/09/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2019
• Type of Device Usage: N
• Patient Sequence Number: 1