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

Model Number	110022
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation in-progress.No samples were 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 diluted solu-cortef medicine on 22.1.Normally by pressing down the plastic activator.Removed the protective plastic from the stopper.Pierced the stopper with a blunt 18g 1 ½ sol-m blunt fill needle attached to 2ml syringe.When drawing the medicine into the syringe, a piece of the stopper floated in the medicine.So the needle bit off a piece of the stopper.Unfortunately there is no unused samples from the customer.
Additional Manufacturer Narrative
There is no evidence of quality issues associated with this complaint based on the archive sample analysis.No septum fragments were identified during the performance of the fragmentation test for medical needles in accordance with iso 7864:2016, annex b.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.

• Brand Name: SOL-M
• Common Device Name: SOL-M BLUNT FILL 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, 325025 wenzhou, zhejiang 32502 5; CH 325025
• Manufacturer Contact: intheran annadurai ; 311 s. wacker dr.,; suite 4100; chicago, IL 60606
• MDR Report Key: 24634540
• Report Number: 3014312726-2026-00021
• Device Sequence Number: 21045792
• Product Code: GAA
• UDI-Device Identifier: 00818392015294
• UDI-Public: (01)00818392015294(10)02503011
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: NA
• 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): 04/10/2026

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: 110022
• Device Lot Number: 02503011
• 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: 02/18/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2025
• 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