MAUDE Adverse Event Report: MEDSOURCE LABS LLC MCKESSON; MCKESSON PUSH BUTTON BC SAFETY IV CATHETER, YELLOW, 24G X 3/4"

Model Number	200-IVRWB2434
Medical Device Problem Codes	Activation Failure (3270); Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the batch manufacturing 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.Retained samples from the same lot were also investigated for visual inspection and functional testing of the safety mechanism.During the testing of the retained samples from the same 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 defects: - the spring mechanism may be damaged, jammed, or not assembled properly, preventing full retraction.- may be an improper inspection carried out by the quality inspector during the in-process testing stage.User error: - the device may not have been handled in accordance with the manufacturer's instructions.- safety mechanism may have failed due to mishandling by the user/health professional.
Event or Problem Description
It was reported by the customer that the needle is not retracting properly.

• Brand Name: MCKESSON
• Common Device Name: MCKESSON PUSH BUTTON BC SAFETY IV CATHETER, YELLOW, 24G X 3/4"
• Manufacturer (Section D): MEDSOURCE LABS LLC; 8600 shelby court; chanhassen MN 55317
• MDR Report Key: 25491418
• Report Number: 3003674698-2026-01221
• Device Sequence Number: 10439214
• Product Code: FOZ
• UDI-Device Identifier: 10612479268149
• UDI-Public: 10612479268149
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2026

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
• Operator of Device: Health Professional
• Device Model Number: 200-IVRWB2434
• Device Catalogue Number: 200-IVRWB2434
• Device Lot Number: 50548/0337
• 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: 03/02/2026
• Initial Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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