MAUDE Adverse Event Report: MEDSOURCE LABS LLC HENRY SCHEIN; SAFETY IV CATHETER 20G X 1

Model Number	5702589
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
While administering the iv, during insertion, the catheter broke off in the 22-year-old male patient's arm.
Additional Manufacturer Narrative
While administering the iv, during insertion, the catheter broke off in the 22 year old male patient's arm.Batch manufacturing records: the batch manufacturing records (bmr) for the reported batch were reviewed.No non-conformities related to the complaint were observed.Supplier verification: reports were verified for any supplier or raw material changes.No changes were incorporated in the process or material.Control samples: no non-conformities related to the reported complaint were observed during the visual inspection and functional testing of the control samples of (b)(6), safety iv cannula with catheter & without small wings & without injection port - 20g.The following tests were performed on the control samples to investigate the reported complaint: visual inspection: no visual defects observed.Gripping of needle with catheter: fine and smooth.Pull test of the catheter: observed within the specification.Leakage test: no leakage observed.Possible root causes per production team: manufacturing defect: may be due to improper inspection of the product.The fitment of catheter may not be appropriate with the hub.The strength (pull force) of the catheter may not be as per the specification/requirement.User error: device may have not been handled according to the manufacturer's instructions.Catheter may have been damaged/deformed due to multiple insertion attempts by the clinician.

• Brand Name: HENRY SCHEIN
• Common Device Name: SAFETY IV CATHETER 20G X 1
• Manufacturer (Section D): MEDSOURCE LABS LLC; 8600 shelby ct suite 100; chanhassen MN 55317
• MDR Report Key: 22038584
• Report Number: 3003674698-2025-00933
• Device Sequence Number: 8123403
• Product Code: FOZ
• UDI-Device Identifier: 10304040151980
• UDI-Public: 10304040151980
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2025

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: 5702589
• Device Catalogue Number: 5702589
• Device Lot Number: 40709/0428
• 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: 04/02/2025
• Initial Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 22 YR
• Patient Sex: Male