MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC., CHICAGO, IL, USA. SOL-MILLENNIUM; SOL-M 30ML LUER LOCK SYRINGE W/O NEEDLE

Model Number	P180030
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No anomalies were found on archived and received samples of record sol-m 30ml luer lock syringe w/o needle ref p180030, lot 04203037 checked.Root cause based on customer statement, the factory thought it maybe that 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.Corrective actions 1.Retrain and educate the assembly operators, requiring all operators to wear the protective clothing and hats well in the designated cloakroom before entering the work area; at the same time, the purification operators shall regularly clean the workshop floor and clean the work-desk, clean the hair if found the hair fall off, and avoid to taking it into the product.2.Retrain and educate all inspectors, required to check each product one by one, 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 data will increase, further evaluation will be performed.This report was initially submitted on 06/17/2024.Due to issues with displaying the initial submission, this submission contains both initial and supplemental information.
Event or Problem Description
"customer reported: "in our nicu they were opening a 30cc luer lock syringe and found a strand of hair inside the packaging.This then triggered a sterile incident report with our quality department.".
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 30ML 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 (Section G): ZHEJIANG LONGDE PHARMACEUTICAL CO., LTD.; no.501, shunfeng rd.; hangzhou, zhejiang 31110 6; CH 311106
• Manufacturer Contact: jarryd franklin ; 311 wacker dr, suite 4100; chicago, IL 60606
• MDR Report Key: 22035415
• Report Number: 3014312726-2024-00259
• Device Sequence Number: 12922000
• Product Code: FMF
• UDI-Device Identifier: 00818392018257
• UDI-Public: (01)00818392018257(10)04203037(17)28022027
• 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: Health Professional,Distributor
• Initial Reporter Occupation: 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: P180030
• Device Lot Number: 04203037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2024
• 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: 03/22/2022
• 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