MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC. MONOJECT; MONOJECT¿ HYPODERMIC SAFETY NEEDLE, GREEN, 21GA X 1IN

Model Number	1182210
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a nurse was using a monoject¿ hypodermic safety needle, green, 21ga x 1in to perform a venipuncture.She activated the safety shield.Upon the shield clicking in place, a large blood spray came from the needle and landed on the patients chairside table.
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 03/19/2024.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 "report type (b1), outcome attributed to adverse event (b2) and brand name (d1)" provided in the initial mdr 3014312726-2024-00188.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, GREEN, 21GA X 1IN
• 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: 22035483
• Report Number: 3014312726-2024-00188
• Device Sequence Number: 8655778
• Product Code: FMI
• UDI-Device Identifier: 10884521544642
• UDI-Public: (01)10884521544642(10)02107198(17)05082026
• 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: 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 Expiration Date: 08/05/2026
• Device Model Number: 1182210
• Device Lot Number: 02107198
• 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: 02/15/2024
• 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: 09/06/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown