MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC HENRY SCHEIN; HENRY SCHEIN SAFETY BLOOD COLLECTION NEEDLE 23G*3/4*12INCH (W/NEEDLE CAP)

Model Number	570-0734
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation in-progress.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.Additionally, no trends related to this issue have been identified during our track-and-trend analysis.
Event or Problem Description
Customer reported that the needle is sliding off and wont stay in place.

• Brand Name: HENRY SCHEIN
• Common Device Name: HENRY SCHEIN SAFETY BLOOD COLLECTION NEEDLE 23G*3/4*12INCH (W/NEEDLE CAP)
• 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,201612, shanghai ; CH
• Manufacturer Contact: mohanapriya kannupaiyan ; 311 s. wacker dr; suite 4100; chicago, IL 60606
• MDR Report Key: 22226603
• Report Number: 3014312726-2025-00130
• Device Sequence Number: 8356450
• Product Code: JKA
• UDI-Device Identifier: 10304040063634
• UDI-Public: (01)10304040063634(10)05405015
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K163073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2025

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: 570-0734
• Device Lot Number: 05405015
• 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: 05/14/2025
• Initial Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2024
• 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