MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC., CHICAGO, IL, USA. SOL-MILLENNIUM; GREER 1ML ALLERGENIC EXTRACT MIXING SYRINGE TRAY 23G*1/2''

Model Number	GROM-23-2
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
"customer reported that we received a customer complaint for optimix two syringes (item# grom-23-2, lot# 02407110), stating that "the syringes were hard to use".The extract was hard to pull up into the syringe.The customer did not provide any photographs, but they have indicated that they intend to return the product.We have assigned this complaint number (b)(4).".
Additional Manufacturer Narrative
There is no evidence of quality issues associated with this complaint based on the 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 04/06/2025.Due to issues with displaying the initial submission, this submission contains both initial and supplemental information.
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 all manufacturer contact office information provided in the initial mdr [3014312726-2025-00073].The previously reported was incorrect.The correct manufacture contact information is below; (b)(6).

• Brand Name: SOL-MILLENNIUM
• Common Device Name: GREER 1ML ALLERGENIC EXTRACT MIXING SYRINGE TRAY 23G*1/2''
• 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: mohanapriya kannupaiyan ; 311 s. wacker dr; suite 4100; chicago, IL 60606
• MDR Report Key: 22035491
• Report Number: 3014312726-2025-00073
• Device Sequence Number: 8655783
• Product Code: FMF
• UDI-Device Identifier: 00818392013795
• UDI-Public: (01)00818392013795(10)02407110
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Consumer,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

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: Lay User/Patient
• Device Model Number: GROM-23-2
• Device Lot Number: 02407110
• 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: 04/01/2025
• 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: 09/22/2021
• 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