MAUDE Adverse Event Report: SVS LLC PREMIERPRO LANCET; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	7580
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The device, when connected to the tubing correctly, caused the blood to not flow.Therefore, giving the impression that it was not inside the vein.When the device was connected half way to the tubing, then the blood would be able to flow.

• Brand Name: PREMIERPRO LANCET
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SVS LLC; 14120 ballantyne corporate; pl ste 425; charlotte NC 28277
• MDR Report Key: 22115524
• Report Number: 22115524
• Device Sequence Number: 7175705
• Product Code: FMI
• UDI-Device Identifier: 00811220033378
• UDI-Public: (01)00811220033378(11)221015(17)271014(10)CDKL1002
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/14/2025
• Report Date (Section F): 05/19/2025

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: 7580
• Device Catalogue Number: 7580
• Device Lot Number: CDKL1002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/30/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/30/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/19/2025