MAUDE Adverse Event Report: MEDSOURCE LABS LLC MCKESSON; MCKESSON SLIDE STYLE SAFETY IV CATHETER 20G X 1

Model Number	200-IVS201
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The catheter was separated from the barrel point.The catheter was barely out of the skin and still in the vein.

• Brand Name: MCKESSON
• Common Device Name: MCKESSON SLIDE STYLE SAFETY IV CATHETER 20G X 1
• Manufacturer (Section D): MEDSOURCE LABS LLC; 8600 shelby ct; chanhassen MN 55317
• MDR Report Key: 22169928
• Report Number: 3003674698-2025-00994
• Device Sequence Number: 9218275
• Product Code: FOZ
• UDI-Device Identifier: 10612479267487
• UDI-Public: 10612479267487
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K150611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/09/2025

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: 200-IVS201
• Device Catalogue Number: 200-IVS201
• Device Lot Number: 41049/0643
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Unknown