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

Model Number	200-IVRW221
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer reported the item was leaking at connection.A review of the batch manufacturing records for the reported lot was completed.The review did not identify any deviations during maufacturing or testing, and all documented parameters were within the approved specification limits.The samples were evaluated through visual inspection and no obervable non-conformances were noted.Simulated testing was conducted and product functioned as intended.Testing conducted using the retention samples demonstrated that the product does not exhibit any manufacturing defects.All results were found to be within the specified limits, confirming compliance with the product's requirements.Possible root causes per the production team: manufacturing defect: may be due to improper molding of 6% taper.Components might not have been assumbled accurately during manufacturing.May be due to improper fitment of the components.User error: device may not have been handled according to the manufacturer's instructions.May be due to the thrombus formation in the body of the iv cannula.May be due to the mating part of the other device not being proper and in compliance with the international standard.Based on testing results of the samples, no non-conformances were identified during the evaluation of the product.All available information and records were reviewed, and there was no evidence indicating a manufacturing, assembly, or functional defect associated with the device.
Event or Problem Description
Customer reported the item was leaking at the connection.This could be indicative of there being a puncture through the catheter which could potentially lead to shearing.

• Brand Name: MCKESSON
• Common Device Name: PUSH BUTTON SAFETY IV CATHETER WITH WINGS 22G X 1IN BLUE
• Manufacturer (Section D): MEDSOURCE LABS LLC; 8600 shelby court; suite 100; chanhassen MN 55317
• MDR Report Key: 24958198
• Report Number: 3003674698-2026-01234
• Device Sequence Number: 10093346
• Product Code: FOZ
• UDI-Device Identifier: 10612479268583
• UDI-Public: 10612479268583
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2026

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-IVRW221
• Device Catalogue Number: 200-IVRW221
• Device Lot Number: 40897/0527
• 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: 03/12/2026
• Initial Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown