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

Model Number	BN1815
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
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 06/03/2024.Due to issues with displaying the initial submission, this submission contains both initial and supplemental information.
Event or Problem Description
Customer reported: the needles took out fragments of the silicone in the vial when handled.There were fragments of silicone that remained floating in the medication and that could be aspirated during the loading of the dose by nurses and reach the patient.The occurrence of this event was during the immediate use of the product and there is no patient involvement.The sample is available for evaluation.As per the report there was no other pertinent product in use during the incident, the incident was not reported to any regulatory agency or competent body, and there was no reported harm or medical intervention required.
Additional Manufacturer Narrative
(b)(4) was initiated at the manufacturing site to track the investigation and application of corrective actions associated with the event.Corrective actions include optimization of sandblasting process and equipment, increase inspection sampling frequency, and update engineering drawings to clarify sandblasting requirements.Corrective actions were verified by inspection of 3 batchs produced after improvement 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.This supplemental mdr is being submitted to correct report type - adverse event and product problem provided in the initial mdr [3014312726-2024-00248].The previously reported type was incorrect.The correct report type is product problem only.(b)(4) was initiated at the manufacturing site to track the investigation and application of corrective actions associated with the event.Corrective actions include optimization of sandblasting process and equipment, increase inspection sampling frequency, and update engineering drawings to clarify sandblasting requirements.Corrective actions were verified by inspection of 3 batchs produced after improvement implementation.The first lot number produced after scar implementation is 02409011.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SMITHS MEDICAL BLUNT FILL NEEDLE 18G*1 1/2"
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC.; 311 south wacker drive; suite 4100; chicago IL 60606
• Manufacturer (Section G): ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.; no. 758, 5th binhai road binha; longwan district; wenzhou, zhejiang province 32502 5; CH 325025
• Manufacturer Contact: jarryd ; 311 south wacker dr.; suite 4100; chicago 60606
• MDR Report Key: 22035518
• Report Number: 3014312726-2024-00248
• Device Sequence Number: 18306675
• Product Code: GAA
• UDI-Device Identifier: 00304040017296
• UDI-Public: 00304040017296
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BN1815
• Device Lot Number: 0221210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2024
• 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; 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown