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	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation in-progress.Received samples were under investigation.A follow up mdr will be submitted with additional information and a device evaluation.
Event or Problem Description
Customer reported that they use sol-m¿ blunt fill needle 18g1½" ref: 110022 needles in the preparation of medicines in the hospital pharmacy.On november 28, the pharmacist in the preparation was preparing medicines when he noticed that there was a small piece of debris/hair at the tip of the needle.He did not use the needle in question, but put it back in the sheath.The needle is available, we have not disposed of it.There is still a small piece of debris visible at the tip.We cannot get a successful picture of it.According to the pharmacist, the debris was actually larger, but some of it has disappeared after the needle has been looked at and put back in the sheath several times.
Additional Manufacturer Narrative
All the retained samples tested were confirmed full compliance with product specifications.The customer sample was investigated and confirmed that the debris observed on the defective unit of sol-m blunt fill needle 18g 1 1/2" (ref# 110022, lot# 02503011) originated from the needle cap.Visual inspection under an optical microscope showed that the debris was located only on the external surface of the cannula, with no traces inside the lumen.The fragments exhibited a reddish color and a plastic appearance.Ftir analysis identified the debris as polypropylene.A spectral comparison with the needle cap confirmed that the material of the fragments matched the cap.This finding is further supported by visible marks inside the needle cap, consistent with the generation of the debris.Based on all available evidence, the debris did not originate from the cannula itself nor from the manufacturing process.The most likely root cause is that the fragment was generated during removal of the needle from the cap, causing the cannula to scrape against the inner cap surface.It is recommended that the customer remove the cap in an axial direction without tilting it, to prevent the cannula from scraping against the walls of the cap and generating debris.Our evaluation of the risk, which follows guidance from iso 14971, indicates that the overall risk for the reported failure is low.This evaluation is based on our track and trend analysis and risk management files which are evaluated and updated constantly based on post market surveillance.As part of our continued commitment to our customers, sol millennium will continue to monitor the complaints trend for the reported failure mode and take any corrective action based on our procedures, 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: 24188167
• Report Number: 3014312726-2026-00008
• Device Sequence Number: 9649490
• 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): 02/12/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 02/12/2026
• 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