MAUDE Adverse Event Report: BAYER MEDICAL CARE INC. MEDRAD STELLANT FLEX CT INJECTION SYSTEM; INJECTOR, CONTRAST MEDIUM, AUTOMATIC

Model Number FLEX

Device Problem Break (1069)

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

Event Date 07/01/2021

Event Type  malfunction  

Event Description

Elderly patient was on the table for her ct scan exam in radiology.The technologists had completed a saline injection with the bayer/medrad power injector.When they went to inject the actual contrast about five seconds into the injection, it stopped injecting, and they heard a popping sound.They immediately stopped the scan and went in to assess the situation.They observed that th actual syringe was broken and was hanging from the injector still connected to the tubing while the bottom plastic was actually stuck in the injector.The patient was not harmed.She was moved to another room so that her scan could be completed.The bayer/medrad injector is under service warranty.The vendor was contacted immediately, and this event was reported to the vendor.We are unable to use the injector until appropriately repaired.We do have a portable injector, which has been connected so that we may continue to provide care to other patients in this scan room.Manufacturer response for contrast injection device, medrad stellant flex ct injection system (per site reporter): product under warranty.

• Brand Name: MEDRAD STELLANT FLEX CT INJECTION SYSTEM
• Type of Device: INJECTOR, CONTRAST MEDIUM, AUTOMATIC
• Manufacturer (Section D): BAYER MEDICAL CARE INC.; 1 bayer drive; indianola PA 15051
• MDR Report Key: 12149095
• MDR Text Key: 260957223
• Report Number: 12149095
• Device Sequence Number: 1
• Product Code: IZQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FLEX
• Device Catalogue Number: FLEX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/07/2021
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26645 DA
• Patient Weight: 70