MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC. SOL-MILLENNIUM; SOL-M HYPODERMIC NEEDLE 18G*1 1/2"

Model Number	111815
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported: when using the hypodermic needle (ref: 111815) to collect medications presented in a bottle with a plastic tip rubber, a piece of rubber found in the syringe from coring issue.This issue seems to occur independently of the batch number (understand often).
Additional Manufacturer Narrative
No samples/pictures were received from the customer for evaluation.The batch number of impacted sol-m hypodermic needle 18g*1 1/2", ref 111815 is unknown and for this reason it was not possible to come back to the manufacturing partner for the archived samples analysis.It is unknown the handling of the product by the end-user, the angle used during insertion procedure etc.It is not possible to define with certainty which of the two components, the needle and the injection stopper, is the cause of the fragmentation issue.This report was initially submitted on 05/08/2024.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.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SOL-M HYPODERMIC NEEDLE 18G*1 1/2"
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC.; 311 south wacker drive; suite 4100; chicago IL 60606
• Manufacturer Contact: jarryd ; 311 south wacker dr.; suite 4100; chicago 60606
• MDR Report Key: 22035557
• Report Number: 3014312726-2024-00228
• Device Sequence Number: 8778755
• Product Code: FMI
• UDI-Device Identifier: 00818392015102
• UDI-Public: 00818392015102
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K112777
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 111815
• Device Lot Number: UNKNOWN
• 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: 04/30/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown