MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC., CHICAGO, IL, USA. SOL-MILLENNIUM; SOL-M 60ML LUER LOCK SYRINGE W/O NEEDLE

Model Number	P180060
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported: for you information and to be documented, last batch that delivered to (b)(6) hospital through arabian health care has quality issue ( 2 syringes has a plastic particle inside the syringe plunger) blow more details regarding the items.
Additional Manufacturer Narrative
No samples/pictures or other evidence of complained issues were received from the customer.For evaluation of impacted sol-m 60ml luer lock syringe w/o needle ref p180060.The batch number is unknown and for this reason it was not possible to come back to the manufacturing partner for the archived samples analysis.It is unknown the handling of the product by the end user, but the high detectability of the particles significantly reduces risk for the patient.Sol-millennium will continue to monitor this kind of issue and in case the number of complaints increases, further evaluation and corrective actions will be taken.In case samples or additional information becomes available from the customer, the complaint will be reanalysed accordingly.This report was initially submitted on 09/25/2024.Due to issues with displaying the initial submission, this submission contains both initial and supplemental information.
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 [3014312726-2024-00317].The previously reported was incorrect.The correct report type is product problem only.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 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.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SOL-M 60ML LUER LOCK SYRINGE W/O NEEDLE
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC., CHICAGO, IL, USA.; 311 s wacker dr, suite 4100; chicago IL 60606
• Manufacturer Contact: jarryd franklin ; 311 wacker dr, suite 4100; chicago, IL 60606
• MDR Report Key: 22035445
• Report Number: 3014312726-2024-00317
• Device Sequence Number: 8641672
• Product Code: FMI
• UDI-Device Identifier: 00818392018264
• UDI-Public: (01)00818392018264
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K222744
• 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): 08/12/2025

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: P180060
• 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: 09/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown