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

Model Number	16-N251S
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the investigation performed, including the review of batch manufacturing records, analysis of archived samples, and evaluation of customer-returned samples, no abnormalities or presence of residual/foreign material on the needle cannula were identified.The manufacturing batch records for the affected lots (csod12-03, csod10-01, csoe04-03) were reviewed and confirmed to be compliant with the established manufacturing and quality control procedures, and no deviations were identified.Additionally, the reported issue could not be reproduced or confirmed during internal testing.The observed residue may be associated with either trace marks from blood clotting at the injection site or a siloxane-related surface phenomenon formed after oxidation of the stainless-steel material.As a preventive measure, the supplier has implemented a process improvement by adding a blunting process after cutting the steel needles and before sharpening, aiming to optimize the needle surface treatment and minimize the possibility of such defects.Additionally, no trends related to this issue have been identified during our track-and-trend analysis.Based on the determined risk priority number, the residual risk related to the complaint is considered acceptable.The investigation is ongoing.We will provide the supplemental report once it is completed.
Event or Problem Description
Customer reported that the needles are leaving a gray/silver metallic residue on patients' skin.Present before vial stopper puncture.Not observed in most other lots of same products.Reproducible across observers and sites.Certain needle lots of exhibit visible gray/dark residue directly out of unopened sterile packaging.When wiped with sterile white gauze or tissue, a gray smear is produced.When used for injection (simulation and patient care), a visible dark mark is at the injection path.When reproducing in one media we were able to cut into, the dark mark tracked through the media along the injection path.
Additional Manufacturer Narrative
The manufacturer is submitting this follow-up report to correct and clarify information provided in the previously submitted manufacturer narrative.The following statement previously reported is hereby withdrawn and should be disregarded: the observed residue may be associated with either trace marks from blood clotting at the injection site or a siloxane-related surface phenomenon formed after oxidation of the stainless-steel material.As a preventive measure, the supplier has implemented a process improvement by adding a blunting process after cutting the steel needles and before sharpening, aiming to optimize the needle surface treatment and minimize the possibility of such defects.The corrected information is as follows: in-process controls are in place during the cannula manufacturing process to monitor the presence of potential processing-related residues or surface traces on the cannula surface.Where such findings are identified, appropriate cleaning actions are performed to ensure compliance with established cleanliness requirements before further use in production.No other conclusions in the previously submitted report are changed based on this clarification.

• 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): 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: 24597368
• Report Number: 3014312726-2026-00017
• Device Sequence Number: 9499859
• Product Code: FMI
• UDI-Device Identifier: 10612479244624
• UDI-Public: (01)10612479244624(10)CSOD12-03,CSOD10-01CSOE04-03
• 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): 04/17/2026

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-N251S
• Device Lot Number: CSOD12-03, CSOD10-01,CSOE04-03
• 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: 02/12/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2024
• 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