MAUDE Adverse Event Report: MEDSOURE LABS LLC MEDSOURCE; TRUESAFE COMFORT BLOOD CONTROL 22G X 1

Model Number	MS-864203
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The plastic of the catheter detached from the hub.When it detached the plastic straw piece of the catheter was in the vein.

• Brand Name: MEDSOURCE
• Common Device Name: TRUESAFE COMFORT BLOOD CONTROL 22G X 1
• Manufacturer (Section D): MEDSOURE LABS LLC; 8600 shelby ct suite 100; chanhassen MN 55317
• MDR Report Key: 22038585
• Report Number: 3003674698-2025-00944
• Device Sequence Number: 8123404
• Product Code: FOZ
• UDI-Device Identifier: 00840155413245
• UDI-Public: 00840155413245
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K223788
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/16/2025

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-864203
• Device Catalogue Number: MS-864203
• Device Lot Number: 40823/0480
• 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: 04/21/2025
• Initial Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown