MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC MONOJECT; MONOJECT 1ML LUER LOCK SYRINGE W/SAFETY NEEDLE 25G*5/8

Catalog Number	11812558
Medical Device Problem Codes	Decoupling (1145); Defective Component (2292)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the investigation, no abnormalities were identified in the production process, batch record, or archived samples.All tested samples met the acceptance criteria per iso 80369-7:2021 for resistance to separation (axial load and unscrewing) and simulation of use.The reported issue of detached/loose needle hub and needle stick could not be confirmed during the investigation due to the absence of returned samples or photographs.Additionally, our risk evaluation, conducted in accordance with iso 14971, indicates that the residual risk associated with this failure mode is low.No trends related to this issue have been identified during our track-and-trend analysis.
Event or Problem Description
The customer reported an incident with a cardinal syringe coming apart and causing a needle stick.

• Brand Name: MONOJECT
• Common Device Name: MONOJECT 1ML LUER LOCK SYRINGE W/SAFETY NEEDLE 25G*5/8
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s. wacker dr; suite 4100; chicago IL 60606
• Manufacturer (Section G): SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO.; no 658; gaochao road201803; shanghai, ; CH
• Manufacturer Contact: mohanapriya kannupaiyan ; 311 s. wacker dr; suite 4100; chicago, IL 60606
• MDR Report Key: 24186397
• Report Number: 3014312726-2026-00006
• Device Sequence Number: 15470261
• Product Code: FMI
• UDI-Device Identifier: 10192253025132
• UDI-Public: (01)10192253025132(10)01312020
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K242291
• 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): 01/27/2026

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 Catalogue Number: 11812558
• Device Lot Number: 01312020
• 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: 12/29/2025
• Initial Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2024
• 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