MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC., CHICAGO, IL, USA. SOL-MILLENNIUM; SOL-CARE 10ML LUER LOCK SAFETY SYRINGE W/EXCH NEEDLE 21G*

Model Number	TW160072IMLD
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	12/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No samples were returned by the customer for analysis, therefore the defect could not be confirmed.However, for continuous improvement, scar (b)(4) was initiated at the manufacturing site to track the investigation and application of corrective actions associated with the event.Planned corrective action includes the implementation of a new "assemble condition inspection" machine to verify proper assembly of components.
Event or Problem Description
"customer complaint no: (b)(4).Customer reported that the needle retracted automatically, causing a needlestick injury to a hospital nurse.Additionally, the complaint frequency for this batch is excessively high, and a full batch replacement is required.Customer complaint no: (b)(4).Customer reported that when first opened and used, the needle suddenly retracted, causing the nursing staff to almost experience a needlestick injury.".
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 report type - adverse event and product problem provided in the initial mdr.The previously reported was incorrect.The correct report type is product problem only.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SOL-CARE 10ML LUER LOCK SAFETY SYRINGE W/EXCH NEEDLE 21G*
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC., CHICAGO, IL, USA.; 311 s wacker dr, suite 4100; chicago IL
• Manufacturer (Section G): ZHEJIANG LONGDE PHARMACEUTICAL CO., LTD.; no.501, shunfeng rd.; hangzhou, zhejiang 31110 6; CH 311106
• Manufacturer Contact: jarryd franklin ; no. 501, shunfeng rd.,; linping district; 311106 hangzhou, zhejiang,, IL ; CH
• MDR Report Key: 22106380
• Report Number: 3014312726-2025-00091
• Device Sequence Number: 8232562
• Product Code: MEG
• UDI-Device Identifier: 00818392015041
• UDI-Public: (01)00818392015041(10)04402055,04405087
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other,Inspection
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TW160072IMLD
• Device Lot Number: 04402055 ,04405087
• 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: 12/25/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 06/03/2025; 08/14/2025; 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2024
• 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