MAUDE Adverse Event Report: LAKE REGION MEDICAL VICTORY 14 (300CM, 18G)

Model Number	901023-22
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The broken catheter cannot be pushed.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue? what is the next course of action? did they need a new victory 14 patient present at time of event?: yes.Patient complications: no patient complications.Reason for unsuccessful procedure: the broken catheter cannot be pushed.Based on the outcome noted above, was the patient sedated when the procedure was canceled?:yes.Local anesthesia device acquired from a distributor?:no.
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
Event or Problem Description
It is broken catheter cannot be pushed.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: it is broken catheter cannot be pushed.What is the next course of action?: they need a new victory 14 patient present at time of event?: yes patient complications: no patient complications reason for unsuccessful procedure: it is broken catheter cannot be pushed.Based on the outcome noted above, was the patient sedated when the procedure was canceled?: yes - local anesthesia device acquired from a distributor?: no.
Additional Manufacturer Narrative
Complaint investigation report is attached to this report.

• Brand Name: VICTORY 14 (300CM, 18G)
• Common Device Name: VICTORY 14 (300CM, 18G)
• Manufacturer (Section D): LAKE REGION MEDICAL; parkmore west business park; galway, H91 C K22; EI H91 CK22
• Manufacturer (Section G): LAKE REGION MEDICAL; parkmore west business park; galway, H91 C K22; EI H91 CK22
• Manufacturer Contact: jaseem saqib ; parkmore west business park; galway, H91 C-K22 ; EI H91 CK22
• MDR Report Key: 17207899
• Report Number: 3006010712-2023-00032
• Device Sequence Number: 5683812
• Product Code: DQX
• UDI-Device Identifier: 08714729826613
• UDI-Public: 08714729826613
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2023

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: Health Professional
• Device Expiration Date: 12/31/2025
• Device Model Number: 901023-22
• Device Catalogue Number: H74939230300180
• Device Lot Number: 7846619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown