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

Model Number	110201030032
Medical Device Problem Codes	Fluid/Blood Leak (1250); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that there is a loss of seal between the end of the tubing and the end of the tulip needle.Once the needle is in the vein and the tube is connected, blood begins to flow into the tube and between the device, causing a significant loss of blood outside the device.New blood collection wings are less optimal in terms of dexterity and quality.Sol-care safety blood collection needles blue and green model.More specifically, the tubing is much less easy and comfortable to use, and the plastic part of the winged needle tends to move when searching for a vein during blood collection.Blood sampling with blue wings, type sol-care 110201030030, batch 0541120006, in the clinic.Hole in the tubing at the connection between the tubing and the white part screwed onto the vacutainer.Blood collection was impossible because the tubes did not fill up due to vacuum loss.Consequence: patient had to be pricked again.
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.We followed up with the customer to obtain incident-related samples and photos, but no further information was available.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.

• Brand Name: SOL-CARE
• 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: 23376971
• Report Number: 3014312726-2025-00203
• Device Sequence Number: 8871825
• 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
• Report Date (Section B): 11/03/2025

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: 09/26/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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