MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-CARE; SOL-CARE 3ML LUER LOCK SAFETY SYRINGE W/O NEEDLE

Model Number	120006IM
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports that the plunger part was breaking when they are pushing out medicines such as testosterone, depo- provera, and pentacel vaccine.The procedure was an im injection.There was no patient harmed.There was a delay in the procedure, since they had to redraw the medication, and some was wasted.They do not have any photos.No patient specifics provided.
Additional Manufacturer Narrative
Based on the investigation, no abnormalities were identified in the batch manufacturing records.Additionally, the evaluation of archived samples, including visual inspection and simulation of use, did not reveal any abnormalities.No trends related to this issue have been identified during our track-and-trend analysis.Based on the determined risk priority number, the residual risk related to the complaint is considered acceptable.
Additional Manufacturer Narrative
No anomalies were observed in the received customer samples of sol-care 3 ml luer lock safety syringe without needle (ref 120006im, lot 05105010).All tests performed, including visual inspection, force-to-push needle hub testing, force-to-engage safety mechanism testing, and simulated use testing, met product specification requirements.The reported plunger breakage is associated with luer lock collapse.However, the issue could not be reproduced under controlled conditions, and no systemic quality issue was identified.

• Brand Name: SOL-CARE
• Common Device Name: SOL-CARE 3ML LUER LOCK SAFETY SYRINGE W/O NEEDLE
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s. wacker dr; suite 4100; chicago IL 60606
• Manufacturer (Section G): SOL-KL (SHANGHAI) MEDICAL PRODUCTS COMPANY LIMI; xinpan road 189; xinqiao,; songjiang,201612, shanghai ; CH
• Manufacturer Contact: mohanapriya kannupaiyan ; 311 s. wacker dr; suite 4100; chicago, IL 60606
• MDR Report Key: 24557099
• Report Number: 3014312726-2026-00016
• Device Sequence Number: 9593652
• Product Code: MEG
• UDI-Device Identifier: 00818392014846
• UDI-Public: (01)00818392014846(10)05105010
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K092430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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: 05/11/2026
• Device Model Number: 120006IM
• Device Lot Number: 05105010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2021
• 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