MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-CARE; SOL-CARE 10ML LUER LOCK SAFETY SYRINGE W/EXCH NEEDLE 21G*1 1/2''

Model Number	160072IM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All the retained samples tested were confirmed full compliance with product specifications.A review of complaints from the past 12 months reveals that only 2 complaints (including this complaint) of sol-care 10ml luer lock safety syringe w/exch needle 21g*1 1/2'' (ref: (b)(4)) have been received for broken - syringe barrel issue.Based on the investigation, it is suspected that the product breakage may have been caused by rough handling during internal material handling within the manufacturing facility.To address and contain this issue, personnel involved in the handling and packaging of components and finished products have been retrained to exercise greater care and to ensure gentler handling throughout the process.This measure aims to minimize the risk of damage to both components and finished products during internal handling and subsequent transportation.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.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.
Event or Problem Description
Customer reported the syringe was cracked.

• Brand Name: SOL-CARE
• Common Device Name: SOL-CARE 10ML LUER LOCK SAFETY SYRINGE W/EXCH NEEDLE 21G*1 1/2''
• 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: intheran annadurai ; 311 s. wacker dr.,; suite 4100; chicago, IL 60606
• MDR Report Key: 24673966
• Report Number: 3014312726-2026-00025
• Device Sequence Number: 18667356
• Product Code: MEG
• UDI-Device Identifier: 00818392015041
• UDI-Public: (01)00818392015041(10)04508099
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K092430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

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: 160072IM
• Device Lot Number: 04508099
• 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: 02/25/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2025
• 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