MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC MCKESSON; NEEDLE, SAFETY 25GX1" (HINGED STYLE)

Model Number	16-N251S
Medical Device Problem Code	Decoupling (1145)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/21/2025
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.Additionally, no trends related to this issue have been identified during our track-and-trend analysis.Additional assessment will be taken if a significant pattern emerges.Unconfirmed.
Event or Problem Description
Customer reported that, after the vaccine injection, the needle remained in the patient's arm when the healthcare provider attempted to withdraw it.Fortunately, the needle was successfully removed using fingers, without the need for tools such as tweezers.It was mentioned that this issue has occurred multiple times.

• Brand Name: MCKESSON
• Common Device Name: NEEDLE, SAFETY 25GX1" (HINGED STYLE)
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s. wacker dr; suite 4100; chicago IL 60606
• Manufacturer (Section G): SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO.; no 658; gaochao road201803; shanghai, ; CH
• Manufacturer Contact: mohanapriya kannupaiyan ; 311 s. wacker dr; suite 4100; chicago, IL
• MDR Report Key: 22282534
• Report Number: 3014312726-2025-00100
• Device Sequence Number: 8467657
• Product Code: FMI
• UDI-Device Identifier: 10612479244624
• UDI-Public: (01)10612479244624(10)CSOD10-01
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2025

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: 16-N251S
• Device Lot Number: CSOD10-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2024
• 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