MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC. MONOJECT; MONOJECT HYPODERMIC SAFETY NEEDLE 30G*1/2"

Model Number	1183005
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No anomalies were found on the archived samples of impacted monoject hypodermic safety needle 30g*1/2" ref 1183005, lot 02204010 checked.No hook, burrs or other cannula defects were found, and all archived samples are within product specification requirements for penetration test performed in accordance with iso 7864:2016 "sterile hypodermic needles for single use" - annex d "test method for measuring the penetration force and drag force for needles".It is unknown the handling of the product by the end-user.This report was initially submitted on 04/08/2024.Due to issues with displaying the initial submission, this submission contains both initial and supplemental information.
Event or Problem Description
"the customer reported that patients were complaining of pain when injecting the needle.".
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 "report type (b1), outcome attributed to adverse event (b2) and brand name (d1)" provided in the initial mdr 3014312726-2024-00199.The previously reported report type (b1) is adverse event and product problem, outcome attributed to adverse event (b2) is required intervention to prevent permanent impairement, brand name (d1) is sol m were incorrect.The correct report type (b1) is product problem only and brand name (d1) is monojet.

• Brand Name: MONOJECT
• Common Device Name: MONOJECT HYPODERMIC SAFETY NEEDLE 30G*1/2"
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC.; 311 south wacker drive; suite 4100; chicago IL 60606
• Manufacturer (Section G): ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.; no. 758, 5th binhai road binha; longwan district; wenzhou, zhejiang province 32502 5; CH 325025
• Manufacturer Contact: jarryd ; 311 south wacker dr.; suite 4100; chicago 60606
• MDR Report Key: 22035498
• Report Number: 3014312726-2024-00199
• Device Sequence Number: 8655787
• Product Code: FMI
• UDI-Device Identifier: 10884521544789
• UDI-Public: 10884521544789
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123684
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1183005
• Device Lot Number: 02204010
• 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: 03/27/2024
• 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: 05/12/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown