MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC. SOL-MILLENNIUM; HENRY SCHEIN SAFETY BLOOD COLLECTION NEEDLE 25G*3/4*12INCH

Model Number	570-0735
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Intraoperative Cardiac Valve Injury (4852)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No pictures/samples or any other evidence of complained issues were received from the customer for evaluation.The batch number of impacted henry schein safety blood collection needle 25g*3/4*12 inch (w/needle cap), ref 570-0735 was not provided and for this reason it was not possible to come back to the manufacturing partner for the archived sample analysis.This report was initially submitted on 05/08/2024.Due to issues with displaying the initial submission, this submission contains both initial and supplemental information.
Event or Problem Description
Customer reported: the customer advised that the blood would spill out.The customer disposed of the defective item.
Additional Manufacturer Narrative
This report when initially submitted encountered an internal issue potentially related to database connectivity.This issue was identified while implementing capa-57 which was opened following an fda inspection.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: HENRY SCHEIN SAFETY BLOOD COLLECTION NEEDLE 25G*3/4*12INCH
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC.; 311 south wacker drive; suite 4100; chicago IL 60606
• Manufacturer Contact: jarryd ; 311 south wacker dr.; suite 4100; chicago 60606
• MDR Report Key: 22035475
• Report Number: 3014312726-2024-00218
• Device Sequence Number: 8655773
• Product Code: MEG
• UDI-Device Identifier: 10304040063641
• UDI-Public: 10304040063641
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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: 570-0735
• 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: 04/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 08/13/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown