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

Model Number	P180060
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the investigation, no abnormalities were identified in the batch manufacturing records or archived samples.All archived samples passed the luer lock stress cracking test according to iso 80369-7, indicating that the product meets the required specifications and quality standards.For lot 04506118, the defective sample received from the customer was used for the investigation and the reported defect was confirmed during the evaluation.The fracture characteristics (twisted profile, irregular sharp edges, and internal deformation marks) are consistent with a rotational stress pattern, suggesting that excessive torsional force may have been applied during use beyond the component's intended operating conditions.At present, this issue appears to be an isolated incident.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.The manufacturer will continue to monitor similar complaints and will take further action if an increasing trend is observed.
Event or Problem Description
Customer reported two occurrences where the syringe tip of the 60 ml luer-lock syringe fractured while unscrewing the luer-lock connection from the easypump.

• Brand Name: SOL-M
• 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: 24518040
• Report Number: 3014312726-2026-00015
• Device Sequence Number: 9723662
• Product Code: FMF
• UDI-Device Identifier: 00818392018264
• UDI-Public: (01)00818392018264(10)04506118,04504103
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2026

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: P180060
• Device Lot Number: 04506118,04504103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2025
• 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