MAUDE Adverse Event Report: MEDSOURCE LABS LLC MCKESSON; MCKESSON PUSH BUTTON SAFETY IV CATHETER WITH WINGS 22G X 1" BLUE

Model Number	200-IVRW221
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577); Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer provided the following description: needle doesn't retract when button is pushed.
Additional Manufacturer Narrative
A review of the batch maufacturing records for the reported lot was completed.The review did not identify any deviations during manufacturing or testing, and all documented parameters were within the approved specification limits.Unused samples from the same lot were returned and evaluated for visual inspection, and functional testing (needle sharpness and safety mechanism).Upon evaluation of the unused product, no non-conformances were observed.Retained samples from the same lot were also investigated.The tests conducted were as follows: visual inspection: functional test - gripping of catheter with needle.Functional test - penetration test.Functional test - bevel heal distance test.Functional test - fitting of retractable button with needle hub.Functional test - spring assembly.Functional test - safety mechanism test.During testing of the retained samples for the reported lot, no manufacturing defects were observed.All results were found to be within the specified limits.No root cause could be identified.The supplier gave the following potential root causes: manufacturing defect: may be due to improper inspection of the product.May be due to the iv cannula tip not being at the appropriate angle or formed within specification.The spring mechanism may be jammed, damaged, or not assembled properly.User error: may be due to the device not being handled according to the manufacturer's instructions.Attempting multiple insertions with the same iv cannula reulting in a dull needle.Dropping or pressing the needle against hard surfaces.Safety mechanism may have failed due to mishandling by the user/health professional.

• Brand Name: MCKESSON
• Common Device Name: MCKESSON PUSH BUTTON SAFETY IV CATHETER WITH WINGS 22G X 1" BLUE
• Manufacturer (Section D): MEDSOURCE LABS LLC; 8600 shelby court; chanhassen MN 55317
• MDR Report Key: 25477789
• Report Number: 3003674698-2026-01243
• Device Sequence Number: 9164823
• Product Code: FOZ
• UDI-Device Identifier: 10612479268583
• UDI-Public: 10612479268583
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 200-IVRW221
• Device Catalogue Number: 200-IVRW221
• Device Lot Number: 50625/0426
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown