MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC. SOL-MILLENNIUM; SOL-M 1ML MIXING SYRINGE TRAY 23G*1/2''

Model Number	181023T
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
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.This report was initially submitted on 04/29/2024.Due to issues with displaying the initial submission, this submission contains both initial and supplemental information.
Event or Problem Description
Customer reported: customer stated that in the last case of mixing syringes he got each tray has at least 1-2 defective syringes out of 25.In one case he opened this last weekend, there were 4 defective syringes out of 25.When he tries to draw up fluid, nothing is able to happen.
Additional Manufacturer Narrative
This report when initially submitted encountered an internal issue potentially related to database connectivity.This issue was identified while implementing capa-57 which was opened following an fda inspection.This supplemental mdr is being submitted to correct manufacturing site address provided in the initial mdr [3014312726-2024-00207].The previously reported was incorrect.The correct manufacturing site address is zhejiang longde pharmaceutical co., ltd no.501, shunfeng rd., linping district 311106 hangzhou zhejiang, china.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SOL-M 1ML MIXING SYRINGE TRAY 23G*1/2''
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC.; 311 south wacker drive; suite 4100; chicago IL 60606
• Manufacturer (Section G): ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.; no. 758, 5th binhai road binha; longwan district; wenzhou, zhejiang province 32502 5; CH 325025
• Manufacturer Contact: jarryd ; no. 501, shunfeng rd.,; linping district; 311106 hangzhou, zhejiang,
• MDR Report Key: 22035548
• Report Number: 3014312726-2024-00207
• Device Sequence Number: 8778752
• Product Code: FMF
• UDI-Device Identifier: 10818392015802
• UDI-Public: (01)10818392015802(17)270228(10)04201057
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K153357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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: 181023T
• Device Lot Number: 04201057
• 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: 04/02/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown