MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-MILLENNIUM; SOL-CARE 5ML LUER LOCK SAFETY SYRINGE W/EXCH NEEDLE 23G*1

Model Number	TW140065IMLD
Medical Device Problem Code	Decoupling (1145)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the determined risk priority number, the residual risk related to this complaint is considered acceptable.However, sol millennium decided to open a supplier corrective action request to the supplier for further investigation of the issue.All actions will be followed in the scar number: (b)(4).Once the scar report is available a detailed corrective action will be shared.This report was initially submitted on 02/20/2025.Due to issues with displaying the initial submission, this submission contains both initial and supplemental information.
Event or Problem Description
Customer reported that the after drawing the medication with a 5ml safety injection needle, the needle hub became detached.
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: SOL-CARE 5ML LUER LOCK SAFETY SYRINGE W/EXCH NEEDLE 23G*1
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s. wacker dr; suite 4100; chicago IL 60606
• Manufacturer (Section G): ZHEJIANG LONGDE PHARMACEUTICAL CO., LTD.; no. 501, shunfeng rd; linping district, 311106; hangzhou, zhejiang,, ; CH
• Manufacturer Contact: jarryd franklin ; 311 s. wacker dr; suite 4100; chicago, IL 60606
• MDR Report Key: 22035633
• Report Number: 3014312726-2025-00035
• Device Sequence Number: 15650503
• Product Code: MEG
• UDI-Device Identifier: 00818392011296
• UDI-Public: (01)00818392011296
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K092430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2025

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: TW140065IMLD
• Device Lot Number: 04410074
• 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: 02/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2024
• 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