MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-MILLENNIUM; SOL-M 1ML INSULIN SYRINGE W/FIXED NEEDLE 29G*1/2

Model Number	1612912B
Medical Device Problem Codes	Defective Component (2292); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation in-progress.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Customer reported that an operator was injured during the process from the tip of the insulin syringe from original pack.During manipulation before opening of the pack an operator pricked to her finger, because one cover was fell inside the original pack.Due to this was the tip of the syringe bent.Unfortunately, she didn't notice before the manipulation that the cover is fell.
Additional Manufacturer Narrative
Our evaluation of the risk, which follows guidance from iso 14971, indicates that the overall risk for the reported failure is low.This evaluation is based on our track and trend analysis and risk management files which are evaluated and updated constantly based on post market surveillance.There is no evidence of quality issues associated with this complaint based on the return sample and archive sample analysis.Based on the investigation of received sample analysis, the warranty seal impressions on both the syringe barrel and the needle cap were consistent with the expected production process and confirm that the needle cap was properly mounted.This concludes that the manufacturing process was carried out correctly and without any issues.The damage observed in the affected sample is likely due to subsequent handling.As part of our continued commitment to our customers, 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.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SOL-M 1ML INSULIN SYRINGE W/FIXED NEEDLE 29G*1/2
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s. wacker dr.,; suite 4100; chicago IL 60606
• Manufacturer (Section G): PROMISEMED HANGZHOU MEDITECH CO.,LTD; no.1388 cangxing street; cangqian community,yuhang dist; hangzhou city, zhejiang 31112 1; CH 311121
• Manufacturer Contact: intheran annadurai ; 311 s. wacker dr.,; suite 4100; chicago, IL 60606
• MDR Report Key: 22218667
• Report Number: 3014312726-2025-00136
• Device Sequence Number: 8157990
• Product Code: FMF
• UDI-Device Identifier: 00818392010893
• UDI-Public: (01)00818392010893(10)07206033
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K153537
• 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): 06/24/2025

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: 1612912B
• Device Lot Number: 07206033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2022
• 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