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 Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that the needle that leaked next to it.The photo shows porosity that is not visible to the naked eye.
Additional Manufacturer Narrative
Sol-millennium received 200 unused samples of the impacted sol-care safety blood collection needle 23g*3/4*7inch (ref# (b)(4), lot# 05412006) from the customer for evaluation.All 200 returned samples, along with an archive sample, were thoroughly analyzed, and no evidence of quality issues was identified in relation to this complaint.Based on the determined risk priority number, the residual risk related to the complaint is considered acceptable.However, scar (b)(4) has been opened to further and more thoroughly analyze the manufacturing process, any corrective actions will be share once the scar report will be ready.
Additional Manufacturer Narrative
Sol-millennium initiated a supplier corrective action request (scar) to investigate the reported issue.The potential root cause was attributed to unintended mechanical contact during the automated assembly process, which may result in localized damage to the pvc tubing.The observed defect rate is very low and does not indicate a systemic issue.Appropriate preventive and corrective measures were implemented, including updates to maintenance procedures and reinforcement of routine equipment inspection and control requirements across relevant assembly line.In addition, visual marking indicators were introduced on critical fasteners to enable immediate identification of any loosening during routine checks.The effectiveness of the implemented actions is being monitored.Batch 05512031 is the first batch produced following implementation.A risk evaluation conducted in accordance with iso 14971 concluded that the overall risk associated with this issue remains low, based on available data and ongoing post-market surveillance activities.Sol-millennium will continue to monitor complaint trends and will take further actions, if necessary, in accordance with established procedures.

• 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: 24051790
• Report Number: 3014312726-2026-00004
• Device Sequence Number: 9494446
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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: 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: 12/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 03/23/2026
• 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