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

Model Number	GROM-23-2
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that the optimix two syringes (item# grom-23-2, lot# 04204017), stating that "during the mixing process the syringe popped out and broke".The customer did not provide any photographs and they have indicated that they do not intend to return the reported product.
Additional Manufacturer Narrative
Based on comprehensive investigation, including batch record review, archived sample evaluation, and simulation of use, no manufacturing defects or abnormalities were identified in the affected batch (lot: 04204017).All tested samples met the required quality standards and functional performance criteria.The issue could not be reproduced during internal testing and could not be confirmed from the provided pictures.As no physical sample was returned, the root cause could not be confirmed.Additionally, no trends related to this issue have been identified during our track-and-trend analysis.Based on the determined risk priority number, the residual risk related to the complaint is considered acceptable.

• Brand Name: GREER
• Common Device Name: GREER 1ML ALLERGENIC EXTRACT MIXING SYRINGE TRAY 23G*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. 501, shunfeng rd.,; linping district; 311106 hangzhou, zhejiang, ; CH
• Manufacturer Contact: mohanapriya kannupaiyan ; 311 s. wacker dr; suite 4100; chicago, IL 60606
• MDR Report Key: 24843326
• Report Number: 3014312726-2026-00024
• Device Sequence Number: 5651130
• Product Code: FMF
• UDI-Device Identifier: 00818392013795
• UDI-Public: (01)00818392013795(10)04204017
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/10/2026

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: GROM-23-2
• Device Lot Number: 04204017
• 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: 03/12/2026
• Initial Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2022
• 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