MAUDE Adverse Event Report: MEDSOURCE LABS LLC MEDSOURCE; TRUESAFE SAFETY IV CATHETER 22G

Model Number	MS-84422
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The needle did not fully retract after pressing button.

• Brand Name: MEDSOURCE
• Common Device Name: TRUESAFE SAFETY IV CATHETER 22G
• Manufacturer (Section D): MEDSOURCE LABS LLC; 8600 shelby ct; chanhassen MN 55317
• MDR Report Key: 22964460
• Report Number: 3003674698-2025-01060
• Device Sequence Number: 18455841
• Product Code: FOZ
• UDI-Device Identifier: 00816703020807
• UDI-Public: 00816703020807
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/04/2025

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 Model Number: MS-84422
• Device Catalogue Number: MS-84422
• Device Lot Number: 30991/0623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown