MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC., CHICAGO, IL, USA. SOL-MILLENNIUM; MONOJECT 1ML SYRINGE W/HYPODERMIC SAFETY NEEDLE 27G*1/2

Model Number	11812705
Medical Device Problem Code	Decoupling (1145)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
"customer reported that they are experiencing a couple of needlesticks with the syringe/needle set, monoject 27g x 1/2" needle.The needle sticks have occurred after attempting to engage the safety cap on the needle by pressing the wing tab on a table or other hard surface.They actually teach this method vs using the other hand to engage safety caps.The needle portion became dislodged "popped off" flying back at the employee and sticking into their hand causing a needle stick.The luer-loc doesn't appear cracked or distorted in any way.
Additional Manufacturer Narrative
No sampels were provided buy the customer for evaluation.Additionally, 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 continue to monitor for this kind of issue.Additional assessment will be taken if a significant pattern emerges.Unconfirmed.This report was initially submitted on 04/23/2025.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.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: MONOJECT 1ML SYRINGE W/HYPODERMIC SAFETY NEEDLE 27G*1/2
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC., CHICAGO, IL, USA.; 311 s wacker dr, suite 4100; chicago IL
• 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: 22106378
• Report Number: 3014312726-2025-00099
• Device Sequence Number: 8232560
• Product Code: FMF
• UDI-Device Identifier: 10884521544796
• UDI-Public: (01)10884521544796(10)01108051
• 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,Followup
• Report Date (Section B): 08/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/06/2026
• Device Model Number: 11812705
• Device Lot Number: 01108051
• 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: 04/11/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 06/03/2025; 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2021
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown