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

Model Number	MS-86422
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The catheter came off the port while the nurse was removing the iv.The patient was taken to the er and they had to make an incision for removal under ultrasound.

• Brand Name: MEDSOURCE
• Common Device Name: TRUESAFE COMFORT BLOOD CONTROL 22G X 1
• Manufacturer (Section D): MEDSOURCE LABS LLC; 8600 shelby ct suite 100; chanhassen MN 55317
• MDR Report Key: 21447341
• Report Number: 3003674698-2025-00889
• Device Sequence Number: 7195767
• Product Code: FOZ
• UDI-Device Identifier: 00840155409750
• UDI-Public: 00840155409750
• Combination Product (Y/N): N
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/24/2025

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-86422
• Device Catalogue Number: MS-86422
• Device Lot Number: 40042/0013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2025
• Initial Report FDA Received Date: 02/24/2025
• Date Device Manufactured: 04/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown