MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-MILLENNIUM; SOL-M 60ML LUER LOCK SYRINGE W/O NEEDLE

Model Number	P180060
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As a replacement for the initial product which is out of stock, we are receiving the company sol-millenium medical.The piston of these syringes and it is very difficult to adjust a volume.The piston moves as soon as we no longer hold it in place.
Additional Manufacturer Narrative
Following a thorough investigation into the reported issue, we carefully reviewed the device history record and analyzed archived samples from the same lot.No anomalies were found during the dhr review, and the samples met the required specifications in accordance with iso 7886-1:2017.Additionally, no trends related to this issue were identified during the track-and-trend analysis.However, as a further improvement to the device, an increase in the diameter of the gasket ring has been evaluated in order to slightly increase the friction of the gasket during piston movement.This modification will be managed in accordance with the change control procedure through the initiation of an engineering change request (ecr).

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SOL-M 60ML LUER LOCK SYRINGE W/O NEEDLE
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s. wacker dr; suite 4100; chicago IL 60606
• Manufacturer (Section G): ZHEJIANG LONGDE PHARMACEUTICAL CO., LTD; no. 501, shunfeng rd.,; linping district; 311106 hangzhou, zhejiang ; CH
• Manufacturer Contact: mohanapriya kannupaiyan ; 311 s. wacker dr; suite 4100; chicago, IL 60606
• MDR Report Key: 22295927
• Report Number: 3014312726-2025-00051
• Device Sequence Number: 8819690
• Product Code: FMF
• UDI-Device Identifier: 00818392018264
• UDI-Public: (01)00818392018264(10)04312090
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K222744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2025

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: P180060
• Device Lot Number: 04312090
• 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: 03/05/2025
• Initial Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/26/2023
• 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