MAUDE Adverse Event Report: MEDSOURCE LABS LLC HENRY SCHEIN; HENRY SCHEIN SAFETY IV CATHETER 22G X 1

Model Number	5702587
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During an egd (esophagogastroduodenoscopy) procedure it was found that the fluid was leaking from where the cannula connected to the catheter.When they took the dressing off to further investigate that is when it was realized the cannula was detached from the catheter and had remained in the arm of an 18 year old male patient.This was in the right antecubital vein of the patient.The cannula was removed by a vascular surgeon under local anesthetic.The patient had to transfer to the emergency room and have the cannula removed.The patient had to receive stitches to close the removal site.

• Brand Name: HENRY SCHEIN
• Common Device Name: HENRY SCHEIN SAFETY IV CATHETER 22G X 1
• Manufacturer (Section D): MEDSOURCE LABS LLC; 8600 shelby court; chanhassen MN 55317
• MDR Report Key: 24262556
• Report Number: 3003674698-2026-01186
• Device Sequence Number: 10726134
• Product Code: FOZ
• UDI-Device Identifier: 00304040151990
• UDI-Public: 00304040151990
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

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: 5702587
• Device Catalogue Number: 5702587
• Device Lot Number: 50238/0145
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown