MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC. MONOJECT; MONOJECT 3ML LUER LOCK SYRINGE W/SAFETY NEEDLE 21G*1 1/2

Model Number	11832115
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Intraoperative Cardiac Valve Injury (4852)
Date of Event	01/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is no evidence of quality issues associated with this complaint based on the return sample and 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 05/08/2024.Due to issues with displaying the initial submission, this submission contains both initial and supplemental information.
Event or Problem Description
Customer reported: the customer reported that the rn used the new syringes to draw up toradol for a patient, went to administer the medication and it shot out the side of the hub and didn't inject.The rn stated this is the 3rd time she has had one of the new syringes break.She stated that usually if they break, its when they tighten the needle on the end, it breaks the luer lock and the needle pops off.
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 brand name provided in the initial mdr.The previously reported was incorrect.The correct brand name is monoject.

• Brand Name: MONOJECT
• Common Device Name: MONOJECT 3ML LUER LOCK SYRINGE W/SAFETY NEEDLE 21G*1 1/2
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC.; 311 south wacker drive; suite 4100; chicago IL 60606
• Manufacturer (Section G): SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO.,; no 658 gaochao road 201803; shanghai, 20180 3; CH 201803
• Manufacturer Contact: jarryd ; 311 south wacker dr.; suite 4100; chicago 60606
• MDR Report Key: 22035544
• Report Number: 3014312726-2024-00219
• Device Sequence Number: 8778751
• Product Code: FMF
• UDI-Device Identifier: 10884521544543
• UDI-Public: 10884521544543
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K241821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,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: 11832115
• Device Lot Number: 01304019
• 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: 04/24/2024
• 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: 05/17/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown