MAUDE Adverse Event Report: MEDSOURCE LABS LLC MCKESSON BRANDS; MCKESSON SLIDE STYLE SAFETY IV CATHETER 22G X 1"

Model Number	200-IVS221
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch manufacturing records: the batch manufacturing records (bmr) for the reported batch were reviewed.No non-conformities related to the complaint were observed in the reports.Supplier verification: reports were verified for any supplier changes or raw material changes.No changes were incorporated in the process or materials.Control samples: no non-conformities related to the reported complaint were observed during the visual inspection and functional testing of the control samples of the sliding safety iv catheter.The following tests were performed on the control samples to investigate the reported complaint: visual inspection: no visual defects observed in the product.Pull test of the catheter: observed within the specification.Leakage test: no leakage observed in the product.Possible root causes per production team: user error: the device may not have been used as intended by the manufacturer.The catheter may have been damaged or deformed due to multiple insertion attempts by the end user.The catheter might have been pulled or twisted excessively during or after insertion.Conclusion: based on the root cause analysis and the results obtained from the tests carried out on the control samples of the reported batch, it is concluded that the product does not contain a manufacturing defect.The most likely cause is user-related, such as improper handling or excessive mechanical stress during use.The product meets the specified requirements while tested.
Event or Problem Description
Plastic clear tip of the catheter broke off inside the patient.After the incident, the nurse had to apply pressure to milk the catheter out of the patient's vein.She then proceeded to start another iv.The catheter tip broke off the ridged catheter hub.No medical treatment was necessary.

• Brand Name: MCKESSON BRANDS
• Common Device Name: MCKESSON SLIDE STYLE SAFETY IV CATHETER 22G X 1"
• Manufacturer (Section D): MEDSOURCE LABS LLC; 8600 shelby ct; suite 100; chanhassen MN 55317
• MDR Report Key: 24809233
• Report Number: 3003674698-2026-01229
• Device Sequence Number: 10667351
• Product Code: FOZ
• UDI-Device Identifier: 10612479267548
• UDI-Public: 10612479267548
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2026

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-IVS221
• Device Catalogue Number: 200-IVS221
• Device Lot Number: 50841/0586
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/07/2026
• 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