MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-MILLENNIUM; SOL-CARE 1ML TB SAFETY SYRINGE W/FIXED NEEDLE 25G*1

Model Number	100034IM
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is no evidence of quality issues associated with this complaint based on the return sample and archive sample 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.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
Customer reported while transferring the vaccine dose from the vial, the needle detached and retracted into the syringe body during the withdrawal movement of the plunger.
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.This supplemental mdr is being submitted to correct type of investigation code provided in the initial mdr 3014312726-2025-00012.The previously reported type of investigation code - 4101 (related medical device from same lot returned) was incorrect.The correct type of investigation code is 10 (actual/suspected device returned).

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SOL-CARE 1ML TB SAFETY SYRINGE W/FIXED NEEDLE 25G*1
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s. wacker dr; suite 4100; chicago IL 60606
• Manufacturer (Section G): SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO.,; no 658 gaochao road201803; shanghai; CH
• Manufacturer Contact: jarryd franklin ; 311 s. wacker dr; suite 4100; chicago
• MDR Report Key: 22035698
• Report Number: 3014312726-2025-00018
• Device Sequence Number: 8733634
• Product Code: MEG
• UDI-Device Identifier: 10818392015086
• UDI-Public: (01)10818392015086
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K092430
• 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
• 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 Expiration Date: 12/01/2025
• Device Model Number: 100034IM
• Device Lot Number: 01012040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2025
• 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: 04/09/2021
• 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