MAUDE Adverse Event Report: BAYER MEDICAL CARE INC MEDRAD ARTERION POWER INJECTOR; INJECTOR AND SYRINGE, ANGIOGRAPHIC

Lot Number 302208

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 04/27/2021

Event Type  malfunction  

Event Description

The injector in room 2 failed to work again when needed in a case that couldn't be done with out a power injector.Fda safety report id # (b)(4).

• Brand Name: MEDRAD ARTERION POWER INJECTOR
• Type of Device: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): BAYER MEDICAL CARE INC; indianola PA 15051
• MDR Report Key: 11783162
• MDR Text Key: 249483850
• Report Number: MW5101200
• Device Sequence Number: 1
• Product Code: DXT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 302208
• 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: 62 YR