MAUDE Adverse Event Report: LIEBEL-FLARSHEIM INJ. OPTIV DH,SI W/OEM

Model Number	844005
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	11/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Overall investigation summary: a complaint was received on optivantage injector 844005 serial number (b)(6) alleging that there was a presence of air bubbles when reading images.There were no adverse impacts for any of the patients related to this complaint.Per customer request, guerbet service was dispatched to the site and evaluated the injector.Service found no alarms nor any other issue during the evaluation.The injector was fully functional and compliant.Guerbet's complaint tracking system was reviewed and showed no related complaint activity for this device.Impact assessment summary: no injury to the patient/user reported imdrf codes: b01, c23, c19, d11, d14.Root / probable cause code.Process/methods - inadequate/incorrect procedure.Root / probable cause summary: refer to investigation summary.No additional capa required at this time.Guerbet quality will continue to monitor and trend for similar issues.These trends and issues are reported on during quality metrics review and during the management reviews to consider input for additional corrective action.Disposition summary: unit returned to customer use.
Event or Problem Description
This case was reported by a facility in france on (b)(6) 2024.Customer states that there was the presence of air bubbles when reading images.

• Brand Name: INJ. OPTIV DH,SI W/OEM
• Common Device Name: INJ. OPTIV DH,SI W/OEM
• Manufacturer (Section D): LIEBEL-FLARSHEIM; 2111 e. galbraith rd; cincinnati OH 45237
• Manufacturer Contact: jacob miller ; 2111 e. galbraith rd; cincinnati, OH 45237 ; 5139485765
• MDR Report Key: 20879973
• Report Number: 1518293-2024-00022
• Device Sequence Number: 8928537
• Product Code: IZQ
• UDI-Device Identifier: 10746190002710
• UDI-Public: 0110746190002710
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K063503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 12/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 844005
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown