MAUDE Adverse Event Report: BAYER MEDICAL CARE INC. MEDRAD® STELLANT FLEX SYRINGE KIT; INJECTOR AND SYRINGE, ANGIOGRAPHIC

Model Number FLEXD-150-SCS

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2022

Event Type  malfunction  

Event Description

3 mri power injector syringe kits failed at the time of set up in prep for 2 different mri exams and 1 ct exam.Tubing became disconnected at the tubing connection to the connector.No patient involvement - we are just noting trend.

• Brand Name: MEDRAD® STELLANT FLEX SYRINGE KIT
• Type of Device: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): BAYER MEDICAL CARE INC.; 1 bayer drive; indianola PA 15051
• MDR Report Key: 13795040
• MDR Text Key: 287338380
• Report Number: 13795040
• Device Sequence Number: 1
• Product Code: DXT
• 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: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: FLEXD-150-SCS
• Device Catalogue Number: FLEXD-150-SCS
• Device Lot Number: 8607812
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/25/2022
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1