MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-MILLENNIUM; SOL-CARE SAFETY NEEDLE 25G*5/8"

Model Number	SN2558
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report was initially submitted on 01/13/2025.Due to issues with displaying the initial submission, this submission contains both initial and supplemental information.
Event or Problem Description
"customer reported writer was vaccinating child with mmr-var vaccine with a new supply of 5/8th needle sol-care sn (b)(6).When writer went to vaccinate child, the customer reported liquid solution had leaked between the syringe and the needle and splashed up into father's face who was holding the child and splashed into his eye.Father reported he was okay, however child received and ineffective dose.Child then required to be reimmunized with an effective dose immediately after.After the event, writer then took a new 5/8th hypodermic needle (sol-care) and tightened it onto a new 3 ml syringe; to further investigate/practice.I tightened it with the same amount of force i typically used with without issue, and a 2nd 5/8th sol-care needle cracked again, close to the base of the safety shield.Another colleague then took another of the new 5/8th sol-care needles and was unable to tighten it to another 3 ml syringe, as it seemed that the threads were stripped on her 5/8th safety sol-care needle and would not tighten on her syringe at all.
Additional Manufacturer Narrative
No samples or lot numbers were received for evaluation therefore the failure mode could not be verified, and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.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.
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.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.Due to unavailability of batch number, the investigation couldn't be able to conclude.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 this supplemental mdr is being submitted to correct the date of event provided in the initial mdr [3014312726-2025-00005].The previously reported date of event was incorrect.The correct date of event is 2024-12-19.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SOL-CARE SAFETY NEEDLE 25G*5/8"
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s. wacker dr; suite 4100; chicago IL 60606
• Manufacturer Contact: jarryd franklin ; 311 s. wacker dr; suite 4100; chicago
• MDR Report Key: 22035613
• Report Number: 3014312726-2025-00005
• Device Sequence Number: 21029700
• Product Code: FMI
• UDI-Device Identifier: 00818392010480
• UDI-Public: (01)00818392010480
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: SN2558
• Device Lot Number: UNKNOWN
• 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: 01/09/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 05/29/2025; 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown