MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-MILLENNIUM; SOL-CARE SAFETY BLOOD COLLECTION NEEDLE 23G*3/4*7INCH

Model Number	110201030032
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported when the nurse took a blood sample, blood flowed down the wing.They noticed an air leak in the tubing at the junction with the tip.They had to repeat the blood test.
Additional Manufacturer Narrative
Investigation inprogress.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
There is no evidence of quality issues associated with this complaint based on the 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.Additional assessment will be taken if a significant pattern emerges.
Additional Manufacturer Narrative
Sol millennium received 200 unused samples of the impacted sol-care safety blood collection needle 23g*3/4*7inch (ref# 110201030032, lot# 05412006) from the customer for evaluation.All 200 returned samples were thoroughly analyzed, and no evidence of quality issues was identified in relation to this complaint.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SOL-CARE SAFETY BLOOD COLLECTION NEEDLE 23G*3/4*7INCH
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s. wacker dr.,; suite 4100; chicago IL 60606
• Manufacturer (Section G): SOL-KL (SHANGHAI) MEDICAL PRODUCTS COMPANY LIMITED; xinpan road 189; xinqiao; songjiang, shanghai 20161 2; CH 201612
• Manufacturer Contact: intheran annadurai ; 311 s. wacker dr.,; suite 4100; chicago, IL 60606
• MDR Report Key: 22847517
• Report Number: 3014312726-2025-00186
• Device Sequence Number: 8457713
• Product Code: JKA
• UDI-Device Identifier: 00818392017274
• UDI-Public: (01)00818392017274(10)05412006
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K163073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/15/2025

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: 110201030032
• Device Lot Number: 05412006
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 10/17/2025; 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2025
• 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