MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-MILLENNIUM; SOL-M 60ML LUER LOCK SYRINGE W/O NEEDLE (BULK, STERILE)

Model Number	P180060BS
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No anomalies were found on archived and received samples of sol-m 60ml luer lock syringe w/o needle (bulk, sterile) ref (b)(4) lot 04402070 checked.Based on manufacturing partner feedback, the reported problem could have been caused by the carelessness of the operator who did not carefully wear protective clothing and hats as required, and by the inspection operator who did not detect the defective part in time, causing it to be released onto the market.The manufacturer partner has personnel to inspect products at every production stage (from the injection molding, assembly, packaging, complete inspection and other processes).If defective products are detected, they are removed in time.For this reason, the complained issue is considered as an isolated case.Manufacturer partner retrained the related operators requiring all personnel to properly wear protective clothing and hats in designated areas before entering the production area; at the same time, cleaning staff should regularly clean the equipment and its work surface.The manufacturer partner retrained the full inspection staff and required each product to be checked one by one.If defective products with hair in the packaging are found, they should be removed in time to avoid entering the market.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.This report was initially submitted on 10/04/2024.Due to issues with displaying the initial submission, this submission contains both initial and supplemental information.
Event or Problem Description
Customer reported: i would like to inform you that during our process we have found hair inside the syringe.
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 (BULK, STERILE)
• 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: 22035665
• Report Number: 3014312726-2024-00321
• Device Sequence Number: 8788365
• Product Code: FMF
• UDI-Device Identifier: 00810018095239
• UDI-Public: (01)00810018095239
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K101359
• 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
• 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: P180060BS
• Device Lot Number: 04402070
• 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: 09/27/2024
• 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: 03/15/2024
• 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