MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-M; SOL-M HYPODERMIC NEEDLE 23G*1 1/4"

Model Number	1123125
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No samples or pictures of the impacted sol-m hypodermic needle 23g*1 1/4" (ref# 1123125, lot# 02107115) were received from the customer for evaluation.All archived samples evaluated were compliant with product specification requirements, including satisfactory performance in stiffness and resistance to breakage testing as per iso 9626:2016.Due to the absence of returned samples or visual evidence, the exact contributing factors associated with the reported issue could not be determined with certainty.This appears to be an isolated incident with a very low complaint occurrence rate.A review of complaints from the past 12 months indicates that this is the only complaint received for sol-m hypodermic needle 23g*1 1/4" (ref: 1123125) related to broken - cannula.Our evaluation of the risk, conducted in accordance with iso 14971, indicates that the overall residual risk associated with the reported failure mode is low and acceptable.This assessment is supported by track-and-trend analysis and risk management documentation, which are continuously reviewed and updated as part of post-market surveillance activities.As part of our continued commitment to product quality and customer safety, sol-millennium will continue to monitor complaints associated with this failure mode and implement appropriate reinforcement or preventive measures should a significant trend emerge.
Event or Problem Description
Customer reported that the hypodermic snapped off in a patient.Clean break off at edge of blue leur lock connector, complete needle retrieved form patient, with no incident to patient".Was medical or surgical intervention required due to the issue? - no was surgery or therapy delayed while the patient was under anesthesia? - no.

• Brand Name: SOL-M
• Common Device Name: SOL-M HYPODERMIC 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 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: 25240025
• Report Number: 3014312726-2026-00036
• Device Sequence Number: 16077402
• Product Code: FMI
• UDI-Device Identifier: 00818392015157
• UDI-Public: (01)00818392015157(10)02107115
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2026

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 Expiration Date: 07/01/2026
• Device Model Number: 1123125
• Device Lot Number: 02107115
• 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: 04/27/2026
• Initial Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2021
• 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