MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC MONOJECT; MONOJECT BLUNT FILL NEEDLE 18G*1 1/2"

Model Number	11811022
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that while preparing an injectable local anaesthetic for a sub tenon block, they drew up 10cc of 0.75% bupivacaine.Upon inspection, they noticed a gray particulate material floating in the syringe.They discarded the initial block and proceeded to prepare a second one.During the preparation of a separate block for a different case, they observed the same gray material floating in the syringe, despite using a different bottle of 0.75% bupivacaine that also had a different lot number.Upon further investigation, they identified that the gray material was originating from the stopper of the bupivacaine bottle during the aspiration process.
Additional Manufacturer Narrative
Due to the unavailability of batch information, the complaint could not be confirmed.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 millenniumcontinues to monitor this kind of issue.Additional assessment will be taken if a significant pattern emerges.Unconfirmed.

• Brand Name: MONOJECT
• Common Device Name: MONOJECT BLUNT FILL NEEDLE 18G*1 1/2"
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s. wacker dr; suite 4100; chicago IL 60606
• Manufacturer Contact: mohanapriya kannupaiyan ; 311 s. wacker dr; suite 4100; chicago, IL 60606
• MDR Report Key: 22382120
• Report Number: 3014312726-2025-00157
• Device Sequence Number: 8410814
• Product Code: GAA
• UDI-Device Identifier: 10884521544826
• UDI-Public: (01)10884521544826
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 07/02/2025

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 Model Number: 11811022
• 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: 06/06/2025
• Initial Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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