MAUDE Adverse Event Report: ACCUVEIN INC. ACCUVEIN AV500; DEVICE, VEIN LOCATION, LIQUID CRYSTAL

Model Number	AV500
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The device claims to see veins at 10mm depth without supporting data.The device makes a claim that isn't supported by data.Fda safety report id # (b)(4).

• Brand Name: ACCUVEIN AV500
• Common Device Name: DEVICE, VEIN LOCATION, LIQUID CRYSTAL
• Manufacturer (Section D): ACCUVEIN INC.
• MDR Report Key: 14236335
• Report Number: MW5109410
• Device Sequence Number: 4445239
• Product Code: KZA
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date (Section B): 04/26/2022

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
• Device Model Number: AV500
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2022
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose