MAUDE Adverse Event Report: ACIST MEDICAL SYSTEMS, INC. POWER INJECTOR SYRINGE

Model Number 242087

Device Problem Break (1069)

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

Event Date 10/05/2023

Event Type  malfunction  

Event Description

Power injector syringe broke off during injection: it shot out towards the floor.The 200 ml syringe inside the injector broke apart during a contrast injection in ct.No injury to the pt.

• Brand Name: POWER INJECTOR SYRINGE
• Type of Device: POWER INJECTOR SYRINGE
• Manufacturer (Section D): ACIST MEDICAL SYSTEMS, INC.
• MDR Report Key: 18057790
• MDR Text Key: 327245495
• Report Number: 18057790
• Device Sequence Number: 1
• Product Code: IZQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 242087
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/17/2023
• Distributor Facility Aware Date: 10/05/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INJECTOR FOR CONTRAST .
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 105 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White