MAUDE Adverse Event Report: MEDSOURCE LABS LLC CLEARSAFE; CLEARSAFE COMFORT 22G X 1IN

Model Number	MS-84222
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The plastic catheter detached inside the vein.

• Brand Name: CLEARSAFE
• Common Device Name: CLEARSAFE COMFORT 22G X 1IN
• Manufacturer (Section D): MEDSOURCE LABS LLC; 8600 shelby ct suite 100; chanhassen MN 55317
• MDR Report Key: 22475097
• Report Number: 3003674698-2025-01008
• Device Sequence Number: 12931014
• Product Code: FOZ
• UDI-Device Identifier: 00816703020647
• UDI-Public: 00816703020647
• Combination Product (Y/N): N
• PMA/510(K) Number: K150611
• 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: Non-Healthcare 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-84222
• Device Catalogue Number: MS-84222
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• 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: Hospitalization; Other
• Patient Sex: Unknown