MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC. SOL-MILLENNIUM; SOL-M 20 ML LUER LOCK SYRINGE W/O NEEDLE

Model Number	P180020
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported: we found that there is a hair inside the piston of the syringe.
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 04/08/2024.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 "manufacturer narrative" provided in the initial mdr 3014312726-2024-00190.The term 'unconfirmed' was inadvertently used; based on the photo received of the suspect sample, the defect can be confirmed.However, the inspection and performed test of the counter-samples did not reveal any anomalies.A possible root cause could be an individual assembly personnel did not wear the protective clothing and hats so good, and the hair fell off and adhered to the inside of the product.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SOL-M 20 ML LUER LOCK SYRINGE W/O NEEDLE
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC.; 311 south wacker drive; suite 4100; chicago IL 60606
• Manufacturer (Section G): ZHEJIANG LONGDE PHARMACEUTICAL CO., LTD.; no. 501, shunfeng rd; linping district; zhejiang, hangzhou 31110 6; CH 311106
• Manufacturer Contact: jarryd ; 311 south wacker dr.; suite 4100; chicago 60606
• MDR Report Key: 22035527
• Report Number: 3014312726-2024-00190
• Device Sequence Number: 20996610
• Product Code: FMF
• UDI-Device Identifier: 00818392018240
• UDI-Public: (01)00818392018240(17)281031(10)04311018
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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): 08/13/2025

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 Model Number: P180020
• Device Lot Number: 04311018
• 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: 01/23/2024
• 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: 11/17/2023
• 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