MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC DROPLET SYRINGE; HTL/DROPLET 1ML INSULIN SYRINGE 31G * 8MM (U-100 INSULIN ONLY)

Model Number	6004
Medical Device Problem Code	Wrong Label (4073)
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
The pictures of the complained htl/droplet 1ml insulin syringe 31g * 8mm (u-100 insulin only) (pe bag), ref 6004 lot 02208049 received by the customer for evaluation confirmed the complained issue.During the manufacturing process of the insulin syringe, individual boxes may be damaged, and the inspector may have to replace them one by one.Therefore, the inspector mistakenly replaced the 1ml cc 30g×5/16"(0.3mm×8mm) central box with the 1ml cc 31g×5/16" (0.25mm×8mm) central box.The inspector and labelling operator did not check the label and packaging specifications of the box, so the wrong box was placed on the market.As a corrective action, the manufacturing partner arranged training for all related workers regarding the label and packaging specifications requirements.Sol-millennium will continue to monitor this kind of issue and in case the number of complaints will increase further evaluations and corrective actions will be taken.This report was initially submitted on 07/17/2024.Due to issues with displaying the initial submission, this submission contains both initial and supplemental information.
Event or Problem Description
Customer reported: customer call from (b)(6) pharmacy to inform us that they received a carton of droplet insulin syringes with the wrong size syringe than what is printed on the label of the carton.Customer does not know the quantity of incorrectly labeled cartons were received, he only reported seeing one carton with that problem.Images have been provided.Sample are no available.
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 brand name (d1) provided in the initial mdr 3014312726-2024-00277.The previously reported brand name was incorrect.The correct brand name is droplet syringe.

• Brand Name: DROPLET SYRINGE
• Common Device Name: HTL/DROPLET 1ML INSULIN SYRINGE 31G * 8MM (U-100 INSULIN ONLY)
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s. wacker dr.,; suite 4100; chicago IL 60606
• Manufacturer (Section G): ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.; 758 binhai 5th avenue, binhai; industrial park, longwan,; wenzhou city,, zhejiang province 32502 5; CH 325025
• Manufacturer Contact: jarryd franklin ; 311 s. wacker dr.,; suite 4100; chicago, IL 60606
• MDR Report Key: 22035616
• Report Number: 3014312726-2024-00277
• Device Sequence Number: 8788339
• Product Code: FMF
• UDI-Device Identifier: 05907996095612
• UDI-Public: (01)05907996095612
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K153537
• 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
• 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: 6004
• Device Lot Number: 02208049
• 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: 11/03/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown