MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC HENRY SCHEIN; HENRY SCHEIN SAFETY NEEDLE 23G*1

Model Number	570-2701
Medical Device Problem Code	Decoupling (1145)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports that when the nurse was recapping the needle after giving a vaccine the safety cap snapped off the device as they pressed it closed.The second incident was when the nurse had just drawn up a vaccine and was in the process of switching out to a different needle but when unscrewed it the syringe separated from the needle tube/hole.There are no photos of the broken needles.
Additional Manufacturer Narrative
Investigation in progress.No samples are available of the suspect device.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Additional Manufacturer Narrative
The reported complaint regarding breakage of the safety mechanism and detachment of the needle could not be confirmed, as no defective samples were received from the customer.Batch record review identified no abnormalities, and there were no changes in raw materials or processes.Archived sample testing, including visual inspection, simulation of activation, engagement force, and cannula traction, demonstrated that all samples met the specified acceptance criteria.Additionally,no trends related to this issue have been identified during our track-and-trend analysis.Our risk evaluation, conducted in accordance with iso 14971, indicates that the residual risk associated with this failure mode is low.Therefore, the residual risk related to this complaint is deemed acceptable based on the calculated risk priority number.

• Brand Name: HENRY SCHEIN
• Common Device Name: HENRY SCHEIN SAFETY NEEDLE 23G*1
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s. wacker dr; suite 4100; chicago IL 60606
• Manufacturer (Section G): PROMISEMED HANGZHOU MEDITECH CO.,LTD; no.1388 cangxing street; cangqian community,yuhang dist; hangzhou city, zhejiang ; CH
• Manufacturer Contact: mohanapriya kannupaiyan ; 311 s. wacker dr; suite 4100; chicago, IL 60606
• MDR Report Key: 23095880
• Report Number: 3014312726-2025-00200
• Device Sequence Number: 15759614
• Product Code: FMI
• UDI-Device Identifier: 10304040154158
• UDI-Public: (01)10304040154158(10)07312015
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2025

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: 570-2701
• Device Lot Number: 07312015
• 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: 09/02/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• 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