MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC MONOJECT; MONOJECT BLUNT FILL NEEDLE 18G*1 1/2"

Model Number	11811022
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that their current blunt tip needle is coring the rubber tops of medication vials leaving a piece of rubber in the medication.
Additional Manufacturer Narrative
There is no evidence of quality issues associated with this complaint based on the archive sample analysis.This issue has been confirmed based on the customer provided picture.Based on the determined risk priority number, the residual risk related to the complaint is considered acceptable.Additionally, no trends related to this issue have been identified during our track-and-trend analysis.Sol millennium continues to monitor this kind of issue.Additional assessment will be taken if a significant pattern emerges.However, sol millennium decided to open a supplier corrective action request to the supplier for further investigation of the issue.All actions will be followed in the scar number: (b)(4).Once the scar report is available a detailed corrective action will be shared.
Additional Manufacturer Narrative
Following a comprehensive investigation of customer complaint (b)(4), associated with product monoject blunt fill needle 18g*1 1/2" (ref: (b)(4), lot: 02405042), no product-related abnormalities were identified.Visual inspection and functional coring tests conducted on 10 returned samples and 25 archived samples revealed no signs of damage, deformation, or coring.All samples met the acceptance criteria outlined in iso 7864:2016(e), annex b.The batch record review confirmed that all manufacturing and inspection processes were completed within specification, with no deviations or changes to raw materials or processes.Based on the above investigation and analysis, the debris generated by the needle tube when puncturing the bottle stopper is related to multiple factors such as the material of the rubber stopper, the angle and position of the puncture, and the number of punctures.It has a certain probability of occurrence in clinical use.Sol-millennium has already opened and completed the supplier corrective action request (scar (b)(4)) with the manufacturing partner.Scar (b)(4) resulted in an optimization of the anti-coring process to reduce the risk of particle generation.The improvements included enhanced sandblasting equipment stability, updated process documentation, increased inspection frequency, and additional operator training.The first lot number produced after scar implementation is 02409011.

• Brand Name: MONOJECT
• Common Device Name: MONOJECT BLUNT FILL NEEDLE 18G*1 1/2"
• 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: 22628536
• Report Number: 3014312726-2025-00174
• Device Sequence Number: 8154867
• Product Code: GAA
• UDI-Device Identifier: 10884521544826
• UDI-Public: (01)10884521544826(10)02405042
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• 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: 11811022
• Device Lot Number: 02405042
• 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: 07/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2024
• 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