MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC MCKESSON; NEEDLE, SAFETY 25GX5/8" (HINGED STYLE)

Model Number	16-N2558S
Medical Device Problem Codes	Break (1069); Decoupling (1145)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that ,on occasion the needle comes off (does not break) and in one incident stays stuck in the patient.No injury occurred.On other occasions, the needle has broken at the hub also.
Additional Manufacturer Narrative
Based on the investigation, which included batch record review, visual inspection, and dimensional and performance testing, no abnormalities were identified in the manufacturing process or product quality of the affected batch.All tested samples met the specified requirements and successfully passed all verification tests, including luer lock dimensional check, axial load resistance,unscrewing resistance, needle hub breakage, and simulation of use.Additionally, our risk evaluation, conducted in accordance with iso 14971, indicates that the residual risk associated with this failure mode is low.No trends related to this issue have been identified during our track-and-trend analysis.
Additional Manufacturer Narrative
Evaluation of the customer-returned samples showed that all components were intact and properly assembled.A sample needle exhibited a slight deformation at the distal end of the needle hub, however, no detachment or leakage was observed during simulated clinical use.This slight deformation does not impact the functionality of the device.The deformation of the plastic component may be attributable to damage to the mold during the molding process.However, on may 3rd, 2025, a new mold was introduced to replace the mold used to manufacture the lot subject to the complaint.

• Brand Name: MCKESSON
• Common Device Name: NEEDLE, SAFETY 25GX5/8" (HINGED STYLE)
• 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 ,wenzhou,, zhejiang province ; CH
• Manufacturer Contact: mohanapriya kannupaiyan ; 311 s. wacker dr; suite 4100; chicago, IL 60606
• MDR Report Key: 24363705
• Report Number: 3014312726-2026-00007
• Device Sequence Number: 5240122
• Product Code: FMI
• UDI-Device Identifier: 10612479244655
• UDI-Public: (01)10612479244655(10)CSOE04-04
• 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): 04/03/2026

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-N2558S
• Device Lot Number: CSOE04-04
• 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: 01/19/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2025
• 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