MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC., CHICAGO, IL, USA. MONOJECT; MONOJECT SAFETY 3ML, 22 X 1.5

Model Number	11832215
Medical Device Problem Codes	Decoupling (1145); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
"the customer reported that the rn drew up medication in a monoject 3 ml syringe with hypodermic safety needle 22 g x 1-1/2"" set.The rn removed the cap from the needle, and was preparing to inject the medication but before they injected the patient the needle fell off of the syringe onto the floor.They didn't lose any medication as they were able to get a sterile needle to put on the syringe and administer the medication.The rn supervisor states she verified with the rn that the rn did twist the needle onto the hub beforehand.".
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 10228/2024.Due to issues with displaying the initial submission, this submission contains both initial and supplemental information.
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 SAFETY 3ML, 22 X 1.5
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC., CHICAGO, IL, USA.; 311 s wacker dr, suite 4100; chicago IL 60606
• Manufacturer (Section G): SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO.,; no 658 gaochao road; shanghai, 20180 3; CH 201803
• Manufacturer Contact: jarryd franklin ; 311 wacker dr, suite 4100; chicago, IL 60606
• MDR Report Key: 22035408
• Report Number: 3014312726-2024-00185
• Device Sequence Number: 20992913
• Product Code: FMF
• UDI-Device Identifier: 10884521544550
• UDI-Public: (01)10884521544550(10)01012021(17)06122025
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2025

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 Expiration Date: 12/06/2025
• Device Model Number: 11832215
• Device Lot Number: 01012021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2021
• 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