MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-MILLENNIUM; SOL-CARE 3ML LUER LOCK SYRINGE W/SAFETY NEEDLE 25G*1 (NEEDLE ASIDE)

Model Number	32510SN
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is no evidence of quality issues associated with this complaint based on the archive sample analysis.Based on the determined risk priority number, the residual risk related to the complaint is considered acceptable.Additionally, no trends related to this issue have been identified during our track-and-trend analysis.Sol millennium continues to monitor this kind of issue.Additional assessment will be taken if a significant pattern emerges.Unconfirmed.
Event or Problem Description
Customer reported that they put one of the needles on a syringe (the syringe it was packaged with) and heard a click.Because they are new to me, i had a close look to see if it was a locking mechanism engaging or something and noticed that the hub was cracked from the bottom.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SOL-CARE 3ML LUER LOCK SYRINGE W/SAFETY NEEDLE 25G*1 (NEEDLE ASIDE)
• 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: mohanapriya kannupaiyan ; 311 s. wacker dr; suite 4100; chicago, IL 60606
• MDR Report Key: 22910724
• Report Number: 3014312726-2025-00195
• Device Sequence Number: 8863301
• Product Code: FMI
• UDI-Device Identifier: 00818392019063
• UDI-Public: (01)00818392019063(10)04011001
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K241821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2025

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 Expiration Date: 10/31/2025
• Device Model Number: 32510SN
• Device Lot Number: 04011001
• 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: 07/29/2025
• Initial Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2020
• 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