MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-MILLENNIUM; SOL-CARE SAFETY BLOOD COLLECTION NEEDLE W/PRE-ATTACHED HOLD

Model Number	110201030004 & 110201030008
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
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.Unconfirmed.This report was initially submitted on 09/05/2024.Due to issues with displaying the initial submission, this submission contains both initial and supplemental information.
Event or Problem Description
Customer reported: incident description: pain when trying to extract blood from a patient immobilized at home.The extraction could not be performed with this material.Consequences for the patient: pain during puncture and possible hematoma after unsuccessful search maneuver to canalize the vein.Comments: since we have been using this type of material, complaints from professionals and patients are daily in the laboratory of this health center, problems with canalizing veins, pain for patients during puncture.Previously, with another manufacturer of wing nuts, this was occasional.
Additional Manufacturer Narrative
This report when initially submitted encountered an internal issue potentially related to database connectivity.This issue was identified while implementing capa-57 which was opened following an fda inspection.This supplemental mdr is being submitted to correct model number, lot number, report type adverse event and product problem provided in the initial mdr [3014312726-2024-00303].The previously reported was incorrect.The correct report type is product problem only.The correct model numbers are 110201030004 & 110201030008.The correct lot numbers are 07401040 & 07208017.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SOL-CARE SAFETY BLOOD COLLECTION NEEDLE W/PRE-ATTACHED HOLD
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s. wacker dr; suite 4100; chicago IL 60606
• Manufacturer Contact: jarryd franklin ; no.1388 cangxing street; cangqian community,yuhang dist; hangzhou city, zhejiang, IL ; CH
• MDR Report Key: 22035625
• Report Number: 3014312726-2024-00303
• Device Sequence Number: 8788342
• Product Code: JKA
• UDI-Device Identifier: 00818392015591
• UDI-Public: (01)00818392015591(01)00818392015614
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 110201030004 & 110201030008
• Device Lot Number: 07401040 & 07208017
• 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: 08/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2024
• 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