MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-MILLENNIUM; SOL-CARE 5ML LUER LOCK SAFETY SYRINGE W/EXCH NEEDLE 23G*1 1/4''

Model Number	TW140065IMLD
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation in progress.No samples are available of the suspect device.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Customer reported that foreign object inside the syringe barrel.
Additional Manufacturer Narrative
Analysis of samples from the same production lot did not reveal any anomalies.However, the suspect sample was not available for comprehensive evaluation, which prevents confirmation of a defect and determination of a potential root cause.As part of our ongoing commitment to product quality and customer safety, sol-millennium will continue to monitor complaint trends for the reported failure mode and will implement corrective actions in accordance with our established procedures should a significant pattern emerge.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SOL-CARE 5ML LUER LOCK SAFETY SYRINGE W/EXCH NEEDLE 23G*1 1/4''
• 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.510 shunfeng road; linping district hangzhou; zhejiang, 31110 6; CH 311106
• Manufacturer Contact: intheran annadurai ; 311 s. wacker dr.,; suite 4100; chicago, IL 60606
• MDR Report Key: 22847519
• Report Number: 3014312726-2025-00183
• Device Sequence Number: 8457715
• Product Code: MEG
• UDI-Device Identifier: 00818392011296
• UDI-Public: (01)00818392011296(10)04411010
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2025

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: 04411010
• 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: 07/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2024
• 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