MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC. SOL-MILLENNIUM; SOL-CARE SAFETY NEEDLE 25G*1"

Model Number	SN2510
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Intraoperative Cardiac Valve Injury (4852)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is no evidence of quality issues associated with this complaint based on the 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 05/08/2024.Due to issues with displaying the initial submission, this submission contains both initial and supplemental information.
Event or Problem Description
"customer reported: writer was drawing up dtap ipv hib hb for a 4 mo.Visit.The cap was difficult to remove from the needle.Writer was loosening the cap on the needle before combining the dtap ipv hb portion into the hib portion in preparation for vaccination.With a lot of effort the cap was removed and then the needle was tightened by the writer to the syringe.When the liquid portion was pushed into the hib portion of the vaccine from the syringe.The liquid sprayed from the hib of the syringe and the mixing was not able to be completed.The vaccine was recorded as wasted.The needle lot number is 07107030.A new vaccine syringe and needle was primed and that was done successfully and the infant was vaccinated.".
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 "device manufacturer date (h4)" provided in the initial mdr 3014312726-2024-00221.The previously reported device manufacturer date (h4) was incorrect.The correct device manufacturer date (h4) is 24-aug-2021.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SOL-CARE SAFETY NEEDLE 25G*1"
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC.; 311 south wacker drive; suite 4100; chicago IL 60606
• Manufacturer (Section G): PROMISEMED HANGZHOU MEDITECH CO.,LTD; no.1388 cangxing street,; cangqian community; yuhang district, zhejiang province 31110 6; CH 311106
• Manufacturer Contact: jarryd ; 311 south wacker dr.; suite 4100; chicago 60606
• MDR Report Key: 22035515
• Report Number: 3014312726-2024-00221
• Device Sequence Number: 8655797
• Product Code: FMI
• UDI-Device Identifier: 00818392010497
• UDI-Public: 00818392010497
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 08/13/2025

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: 06/30/2026
• Device Model Number: SN2510
• Device Lot Number: 07107030
• 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: 04/23/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown