MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC., CHICAGO, IL, USA. SOL-MILLENNIUM; SOL-CARE SAFETY NEEDLE 18G*1 1/2"

Model Number	SN1815
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the testing performed on the archived samples and the determined risk priority number, the residual risk related to this complaint is considered acceptable.As evidence, the customer provided pictures of the impacted sol-care safety needle 18g 1 1/2", ref: sn1815, confirmed the reported issue.The brown substance on the safety mechanism may be oil from injection mold or may be the initial injection parts when the injection machine is restarted.The operators and inspectors have been retrained about the appearance inspection requirement of safety needle.Sol millennium will continue to monitor the complaints trend for the reported failure mode and take any corrective action based on our procedures, if a significant pattern emerges.This report was initially submitted on 02/12/2025.Due to issues with displaying the initial submission, this submission contains both initial and supplemental information.
Event or Problem Description
"the customer reported that they received a complaint from our customer regarding the product sol-care safety needle.A dark/brown color can be seen in the safety mechanism of the needle.The customer has noticed an error in one of the needles.
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-CARE SAFETY NEEDLE 18G*1 1/2"
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC., CHICAGO, IL, USA.; 311 s wacker dr, suite 4100; chicago IL 60606
• Manufacturer (Section G): PROMISEMED HANGZHOU MEDITECH CO.,LTD; no.1388 cangxing street,cangqi; hangzhou, zhejiang 31112 1; CH 311121
• Manufacturer Contact: jarryd franklin ; 311 wacker dr, suite 4100; chicago, IL 60606
• MDR Report Key: 22035469
• Report Number: 3014312726-2025-00024
• Device Sequence Number: 15617246
• Product Code: FMI
• UDI-Device Identifier: 00818392010640
• UDI-Public: (01)00818392010640(17)281130(10)07312030
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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: SN1815
• Device Lot Number: 07312030
• 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: 01/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2024
• 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