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

Model Number	110022
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported: needle bending when adding medication to iv fluid bags.
Additional Manufacturer Narrative
The complained issue related to the impacted sol-m blunt fill needle 18g*1 1/2", ref 110022, lot 02312006 was already analyzed under the previous similar complaint, same batch number and same error code.In the samples analyzed, there were found some pieces with unsharpened tip with a bulge/reborder on the outside.These samples present higher values of penetration into a pu foil compared to the well sharpened tip.This cannula tip configuration is a customized needle tip produced by the manufacturing partner for another customers.The complained issue was caused by the operator's failure to mark/recognize the custom needles, resulting in the flow card number of the needles being mixed with sol millennium's production for the following batches: lot#02312006 (complained batch number), lot#02311085, lot#02403009, lot#02403036 and lot#02403038.· added a new drawing and the corresponding material code for the customized needle tubes, trained inspectors to ensure master the materials required for production, · added the requirements and trained the relevant operators and inspectors in the needle workshop to strictly check the plan sheet, drawing requirements and specified material codes before production, · added sampling requirements for needle tube turns, · added the puncture force requirements for injection needles for dispensing (as a component, before assembling), and trained the relevant inspection personnel about it.Furthermore, sol-millennium quality department will monitor three batches after corrective action implementation to ensure the effectiveness of corrective actions taken and conformity of products delivered.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.This report was initially submitted on 07/18/2024.Due to issues with displaying the initial submission, this submission contains both initial and supplemental information.
Additional Manufacturer Narrative
This complaint was confirmed based on the analysis of customer returned samples.As a result, scar (b)(4) was initiated at the manufacturing site to track the investigation and application of corrective actions associated with the event.Corrective actions include retraining personnel on proper material inspection prior to production, updating inspection sampling requirements and device performance requirements.Corrective actions were verified by inspection of 3 lots after implementation.
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.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SOL-M 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.; 758 binhai 5th avenue, binhai; industrial park, longwan,; wenzhou city,, zhejiang province 32502 5; CH 325025
• Manufacturer Contact: jarryd franklin ; 311 s. wacker dr.,; suite 4100; chicago, IL 60606
• MDR Report Key: 22035622
• Report Number: 3014312726-2024-00281
• Device Sequence Number: 12958906
• Product Code: GAA
• UDI-Device Identifier: 00818392015294
• UDI-Public: (01)00818392015294
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2025

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: 110022
• Device Lot Number: 02312006
• 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: 06/24/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 05/28/2025; 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2024
• 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