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

Model Number	200-IVRB2434
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The catheter sticks when advancing the catheter/straw off the needle during iv start.The catheter also sticks when the needle retraction button is pressed, which has led to two primary concerns: the force of the retraction can pull the catheter out of the vein, requiring the patient to undergo a second iv insertion.In some cases, the needle does not retract, requiring the clinician to manually remove the needle, which increases the risk of accidental needle stick or exposure.
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.Unused samples from the same lot were returned and evaluated for visual inspection, and functional testing (retraction).Upon evaluation of the unused product, no non-conformances were observed.Retained samples from the same lot were also reviewed.The tests conducted were as follows: visual inspection: functional test - fitting of retraction button with needle hub 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 identifed for the issue.The supplier gave the following potential root causes: manufacturing defects: 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.

• Brand Name: MCKESSON
• Common Device Name: MCKESSON PUSH BUTTON BC SAFETY IV CATHETER, YELLOW, 24G X 3/4"
• Manufacturer (Section D): MEDSOURCE LABS; 8600 shelby ct; suite 100; chanhassen MN 55317
• MDR Report Key: 25036044
• Report Number: 3003674698-2026-01237
• Device Sequence Number: 21378826
• Product Code: FOZ
• UDI-Device Identifier: 10612479268057
• UDI-Public: 10612479268057
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 04/29/2026

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-IVRB2434
• Device Catalogue Number: 200-IVRB2434
• Device Lot Number: 41398/0876
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 04/29/2026
• 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