MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-MILLENNIUM; SOL-CARE SAFETY BLOOD COLLECTION NEEDLE 21G*3/4*12INCH

Model Number	110201030031
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/04/2025
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 03/18/2025.Due to issues with displaying the initial submission, this submission contains both initial and supplemental information.
Event or Problem Description
The customer reported that the pca was attempting veni puncture blood draw to patients left ac.After retracting needle into safety plastic tips, plastic tip pinched patients arm at insertion site.Plastic piece pinched patient's arm.After retracting needle, the plastic piece was stuck to patients' arm.
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 all manufacturer contact office information and date of event, product description and udi provided in the initial mdr [3014312726-2025-00060.The previously reported was incorrect.The correct manufacture contact information is below; (b)(4), qa engineer, sol-millennium medical inc, 311 s.Wacker dr., suite 4100, chicago, il 60606, united states, (b)(4).The correct date of event is 04-march-2025.The correct product description is sol-care safety blood collection needle 21g 3/4 12inch (without non-patient needle cap).The correct product udi is (b)(4).

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SOL-CARE SAFETY BLOOD COLLECTION NEEDLE 21G*3/4*12INCH
• 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: mohanapriya kannupaiyan ; 311 s. wacker dr; suite 4100; chicago, IL 60606
• MDR Report Key: 22035768
• Report Number: 3014312726-2025-00060
• Device Sequence Number: 15636779
• Product Code: MEG
• UDI-Device Identifier: 00818392017267
• UDI-Public: (01)00818392017267(10)05104011
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K162030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

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 Expiration Date: 04/15/2026
• Device Model Number: 110201030031
• Device Lot Number: 05104011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• 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: 09/25/2021
• 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