MAUDE Adverse Event Report: MEDSOURCE LABS LLC TRUESAFE; TRUESAFE COMFORT SAFETY IV CATHETER 20G

Model Number	MS-843202
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Catheter detached from hub.

• Brand Name: TRUESAFE
• Common Device Name: TRUESAFE COMFORT SAFETY IV CATHETER 20G
• Manufacturer (Section D): MEDSOURCE LABS LLC; 8600 shelby ct suite 100; chanhassen MN 55317
• MDR Report Key: 22475096
• Report Number: 3003674698-2025-01013
• Device Sequence Number: 8498752
• Product Code: FOZ
• UDI-Device Identifier: 00816703020715
• UDI-Public: 00816703020715
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: MS-843202
• Device Catalogue Number: MS-843202
• Device Lot Number: 41389/0875
• 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: 06/17/2025
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Unknown