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

Model Number	GROM-23-2
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is no evidence of quality issues associated with this complaint based on the return 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 04/29/2024.Due to issues with displaying the initial submission, this submission contains both initial and supplemental information.
Event or Problem Description
"customer reported: we received a customer complaint for 5 cases of optimix two syringes (item# grom-23-2, lot# 07212040), stating that "a hair was found on the syringe once it was opened".The customer sent the attached photographs and has indicated that they do intend to return the product.Can you please initiate and investigation and forward your findings to me.
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 "investigation finding (c) code, investigation conclusion (d) code and manufacturer narrative (h11)" provided in the initial mdr 3014312726-2024-00213.The previously reported investigation finding (c) code, investigation conclusion (d) code and manufacturer narrative (h11) were incorrect.The correct codes were investigation findings (c): 170, investigation conclusion (d): 25 and manufacturer narrative (h11): the pictures received from the customer for evaluation confirmed the complained issue.However, no anomalies were found on archived samples of impacted greer 1ml allergenic extract mixing syringe tray 23g 1/2'' ref grom-23-2, lot 07212040 checked.The manufacturer partner identified as possible root cause of the issue, carelessness of operator who did not carefully wear the protective clothing and hat causing the falling of hair accidentally.The inspectors of the following stages did not detect the defective piece causing the defective device to go in the market.As a corrective action, the manufacturer partner retrained and educated the assembly operators requiring them to correctly wear the protective clothing.Sol-millennium will continue to monitor this kind of issue and in case the number of complaints increases, further evaluations and corrective actions will be taken.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: GREER 1ML ALLERGENIC EXTRACT MIXING SYRINGE TRAY 23G*1/2''
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC.; 311 south wacker drive; suite 4100; chicago IL 60606
• Manufacturer (Section G): PROMISEMED HANGZHOU MEDITECH CO.,LTD; no.1388 cangxing street,; cangqian community; yuhang district, zhejiang province 31110 6; CH 311106
• Manufacturer Contact: jarryd ; 311 south wacker dr.; suite 4100; chicago 60606
• MDR Report Key: 22035537
• Report Number: 3014312726-2024-00213
• Device Sequence Number: 8778745
• Product Code: FMF
• UDI-Device Identifier: 20818392013799
• UDI-Public: 20818392013799
• 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): 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): 08/13/2025

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: GROM-23-2
• Device Lot Number: 07212040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2023
• 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