MAUDE Adverse Event Report: BRACCO INJENEERING SA FASTLOAD MR SYRINGE PACK; INJECTOR, CONTRAST MEDIUM, AUTOMATIC

Model Number	017356
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure: mri successful injection, when drawing back on syringe to remove and dispose, the plunger turned sideways, letting the remaining saline in syringe spill onto injector head and floor.No known harm to patient.Manufacturer response for injector, contrast medium, automatic, fastload mr syringe pack (per site reporter), will obtain.

• Brand Name: FASTLOAD MR SYRINGE PACK
• Common Device Name: INJECTOR, CONTRAST MEDIUM, AUTOMATIC
• Manufacturer (Section D): BRACCO INJENEERING SA; 7905 fuller road; eden prairie MN 55344
• MDR Report Key: 20075495
• Report Number: 20075495
• Device Sequence Number: 11512722
• Product Code: DXT
• UDI-Device Identifier: 17630039300866
• UDI-Public: (01)17630039300866(17)270415(11)240415(10)253725
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/29/2024
• Report Date (Section F): 07/29/2024

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
• Operator of Device: Other
• Device Model Number: 017356
• Device Catalogue Number: 017356
• Device Lot Number: 253725
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Date Report Sent to FDA: 07/29/2024