MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC 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	06/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No anomalies were found on archived samples of sol-m 60ml luer lock syringe w/o needle (bulk, sterile) ref p180060, lot 04401092 checked.Based on the investigation performed, there is no evidence of quality defects associated with the device.However, for the sake of continuous improvement, the following root cause and corrective actions were implemented.Root cause the production site investigation determined that individual assembly personnel may have not had their protective clothing equipped properly, resulting in hair falling off and adhered to the inside date (b)(6) 2024 customer (b)(6) health complaint no.(b)(4) of the product.Corrective actions 1.Retrain and educate the assembly operators, requiring all operators to have their protective clothing properly worn in the designated cloakroom before entering the work area.At the same time, the purification operators shall regularly clean the workshop floor and work desk area.2.Retrain and educate all inspectors to check each product, focusing on the hair and foreign matter in the product, and isolating and scrapping defective products in time.Sol-millennium will continue to monitor this type of issue and if should a strong trend arise, further evaluation will be performed.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.
Event or Problem Description
Customer reported: we have a product complaint that i would like to report in regard to your 60 ml syringe luerlock.This morning while our technician was using the 60 ml syringe to compound a medication a piece of hair was found lodged inside the barrel.Needless to say, this was a brand new in the package syringe that was never used before.This raises concern over quality control and whether we may trust such products to be used at our facilities.Please advise.
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.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SOL-M 60ML LUER LOCK SYRINGE W/O NEEDLE
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s. wacker dr.,; suite 4100; chicago IL 60606
• Manufacturer (Section G): ZHEJIANG LONGDE PHARMACEUTICAL CO., LTD.; no.510 shunfeng road; linping district hangzhou; zhejiang, 31110 6; CH 311106
• Manufacturer Contact: jarryd franklin ; 311 s. wacker dr.,; suite 4100; chicago, IL 60606
• MDR Report Key: 22035627
• Report Number: 3014312726-2024-00316
• Device Sequence Number: 8788343
• Product Code: FMF
• UDI-Device Identifier: 00810018095239
• UDI-Public: (01)00810018095239
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: P180060
• Device Lot Number: 04401092
• 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: 07/01/2024
• 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: 02/18/2024
• 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