MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC MONOJECT; MONOJECT HYPODERMIC SAFETY NEEDLE 22G*1 1/2"

Model Number	1182215
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that their pa was injecting lidocaine and was sprayed in the eye.He states it was coming out the sides and that there was a hole in the plastic needle connection.The pa said he was attempting a tendon sheath injection when the medication sprayed out the side of the plastic hub-needle connection.He confirmed needle was twisted on tightly and attempted injection again and it continued to spray out the sides of the hub, spraying the pa and the patient.Injection aborted.Gauze held to puncture site to obtain haemostasis.New injection drew up and used a 25-gauge needle from a different lot # to proceed with the injection safely.No patient harm noted.
Additional Manufacturer Narrative
There is no evidence of quality issues associated with this complaint based on the archive sample analysis.Additionally, no trends related to this issue have been identified during our track-and-trend 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.

• Brand Name: MONOJECT
• Common Device Name: MONOJECT HYPODERMIC SAFETY NEEDLE 22G*1 1/2"
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s. wacker dr; suite 4100; chicago IL 60606
• Manufacturer (Section G): ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.; no. 758, 5th binhai road; binhai industrial park,; longwan district 325025 wenzho, zhejiang ; CH
• Manufacturer Contact: mohanapriya kannupaiyan ; 311 s. wacker dr; suite 4100; chicago, IL 60606
• MDR Report Key: 22226602
• Report Number: 3014312726-2025-00127
• Device Sequence Number: 8356449
• Product Code: FMI
• UDI-Device Identifier: 10884521544659
• UDI-Public: (01)10884521544659(10)02104058
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2025

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: 05/10/2026
• Device Model Number: 1182215
• Device Lot Number: 02104058
• 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: 05/09/2025
• Initial Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2021
• 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