MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC MONOJECT; MONOJECT HYPODERMIC SAFETY NEEDLE 18G*1"

Model Number	1181810
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that they are currently experiencing cored medication bottles resulting in debris being present in the syringes prior to administration.It was first noted with the medication aponvie but now has occurred with toradol.The same brand needle was used with the different vials.
Additional Manufacturer Narrative
Investigation in progress.No samples are available of the suspect device.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Additional Manufacturer Narrative
Based on the comprehensive investigation, including batch record review, archived sample analysis, returned sample testing, and coring evaluations in accordance with iso 7864:2016, no abnormalities or non-conformances were identified.The manufacturing records confirmed that there were no changes in raw materials or processes, and all inspected samples were within specification.Visual and coring tests did not reveal any defects that could contribute to coring.Therefore, the reported issue could not be reproduced during the investigation, and no systemic or lot-related defect has been identified.Additionally no trends related to this issue have been identified during our track-and-trend analysis.Our risk evaluation, conducted in accordance with iso 14971, indicates that the residual risk associated with this failure mode is low.Therefore, the residual risk related to this complaint is deemed acceptable based on the calculated risk priority number.

• Brand Name: MONOJECT
• Common Device Name: MONOJECT HYPODERMIC SAFETY NEEDLE 18G*1"
• 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.; no. 758, 5th binhai road; binhai industrial park; longwan ,wenzhou,, zhejiang province ; CH
• Manufacturer Contact: mohanapriya kannupaiyan ; 311 s. wacker dr; suite 4100; chicago, IL 60606
• MDR Report Key: 22870265
• Report Number: 3014312726-2025-00188
• Device Sequence Number: 18412359
• Product Code: FMI
• UDI-Device Identifier: 10884521544727
• UDI-Public: (01)10884521544727(10)02403044
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2025

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: 1181810
• Device Lot Number: 02403044
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2024
• 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