MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-MILLENNIUM; SOL-M HYPODERMIC NEEDLE 18G*1 1/2"

Model Number	111815
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that the 18g needle draw from multidose vial suspected leaving fragments of rubber from lid in vial.I have retained vial with floating fragment.Needle used: a sol-m 18g 2023/05 4149 rev 11 ce (b)(4).Ref (b)(4).Lot 02307025.Other dates written 2023-08 and 2028-07-20 xylocaine 2% multidose vial with epi 1:200,000 20 ml vial xa254746 (printed on aluminium cap) lot 9954746 exp 08/2026 din (b)(4) printed on label.
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.Sol millennium continues to monitor this kind of issue.Additional assessment will be taken if a significant pattern emerges.Unconfirmed.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SOL-M HYPODERMIC NEEDLE 18G*1 1/2"
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s. wacker dr; suite 4100; chicago IL 60606
• Manufacturer (Section G): ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.; no. 758, 5th binhai road; binhai industrial park,; longwan district 325025 wenzho, zhejiang ; CH
• Manufacturer Contact: mohanapriya kannupaiyan ; 311 s. wacker dr; suite 4100; chicago, IL 60606
• MDR Report Key: 22225917
• Report Number: 3014312726-2025-00114
• Device Sequence Number: 8356430
• Product Code: FMI
• UDI-Device Identifier: 00818392015102
• UDI-Public: (01)00818392015102(10)02307025
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K112777
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2025

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: 111815
• Device Lot Number: 02307025
• 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: 04/23/2025
• Initial Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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