MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-MILLENNIUM; SOL-M HYPODERMIC NEEDLE 21G*50MM

Model Number	112120
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No anomalies were identified in device master batches 02408013 and 02402032.The needles comply with iso 9626 and iso 7864 and passed chemical tests for acidity/alkalinity, extractable metals, endotoxin, and eo/ech residuals.Validation per iso 10993-1 confirmed biocompatibility, including hemolysis, cytotoxicity, intracutaneous reactivity, sensitization, and acute systemic toxicity.The components (polypropylene, sus304 stainless steel, silicone oil) are chemically stable, with no reported chemical interactions with tc-99m agents such as teceos or hdp technescan.At present, there is no evidence that these materials contribute to pulmonary uptake or imaging artifacts.Sol-millennium will continue monitoring and perform further assessments if a significant pattern emerges.
Event or Problem Description
Customer reported that since the end of 2024, all nuclear medicine physicians in the department have noticed the appearance of pulmonary spots on bone scintigraphy scans in certain patients.Initially, 9 cases were reported to curium, the manufacturer of the radiopharmaceutical used for these examinations.A quality defect in the batches of the radiopharmaceutical concerned was ruled out by the manufacturer, who instead suggested a cause related to injection (blood clots).This hypothesis seems unlikely, as we now have 60 patients affected by these pulmonary spots.Blood clots are described in the scientific literature but remain relatively rare (less than 1/1000).We have looked for other possible causes, and it turns out that since early december 2024, we have changed the reference of hypodermic needles used both for the preparation of the radiopharmaceutical and for drawing the doses to be administered.We therefore wonder whether there could be an interaction between the metal of the needles and the radiopharmaceutical during its preparation.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SOL-M HYPODERMIC NEEDLE 21G*50MM
• 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, 325025 wenzhou, zhejiang 32502 5; CH 325025
• Manufacturer Contact: intheran annadurai ; 311 s. wacker dr.,; suite 4100; chicago, IL 60606
• MDR Report Key: 23035216
• Report Number: 3014312726-2025-00192
• Device Sequence Number: 18445804
• Product Code: FMI
• UDI-Device Identifier: 00818392015751
• UDI-Public: (01)00818392015751(10)02408013
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K123684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2025

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: 112120
• Device Lot Number: 02408013, 02402032
• 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: 08/14/2025
• Initial Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2024
• 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
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Unknown