MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC., CHICAGO, IL, USA. DROPLET; DROPLET INSULIN SYRINGES 31G X 6MM

Model Number	6003
Medical Device Problem Code	Decoupling (1145)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is no evidence of quality issues associated with this complaint based on the received sample and archive sample analysis.Based on the determined risk priority number, the residual risk related to the complaint is considered acceptable.Sol millennium continues to monitor this kind of issue.Additional assessment will be taken if a significant pattern emerges.Unconfirmed.This report was initially submitted on 03/08/2024.Due to issues with displaying the initial submission, this submission contains both initial and supplemental information.
Event or Problem Description
Customer reported: customer stated he's having problems with the caps on his syringes falling off, exposing the needle.He has accidentally pricked his hands with needles that were exposed by caps that were loose and had fallen off.Customer has not had any serious injury outside of the finger pricks from loose caps.He has been able to complete his injections, but he's concerned about the number of loose caps and in the box.
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 and report type (adeverse event and product problem) provided in the initial mdr [3014312726-2024-00184].The previously reported was incorrect.The correct report type is only product problem and the correct brand name is droplet.

• Brand Name: DROPLET
• Common Device Name: DROPLET INSULIN SYRINGES 31G X 6MM
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC., CHICAGO, IL, USA.; 311 s wacker dr, suite 4100; chicago IL
• Manufacturer (Section G): ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD; no.758 5th binhai road; wenzhou, zhejiang 32502 5; CH 325025
• Manufacturer Contact: jarryd franklin ; 311 wacker dr, suite 4100; chicago, IL 60606
• MDR Report Key: 22035410
• Report Number: 3014312726-2024-00184
• Device Sequence Number: 12921999
• Product Code: FMF
• UDI-Device Identifier: 05907996095605
• UDI-Public: (01)05907996095605(10)02205029(17)30052027
• 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: Foreign,Consumer,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 6003
• Device Lot Number: 02205029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2022
• 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