FDA Adverse Event Malfunction Summary report: N

ACCUVEIN VEIN VISUALIZATION SYSTEM POWERED WHEELED STAND

MDR report key: 19764851 · Received July 16, 2024

Report

Report Number
MW5157333
Event Type
Malfunction
Date Received
July 16, 2024
Date of Event
June 25, 2024
Report Date
July 9, 2024
Manufacturer
ACCUVEIN INC.
Product Code
KZA
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NY, US
Reporter Occupation
003
Health Professional
N

Narratives

Description of Event or Problem · 0

BROKEN HF470 ARM FELL ONTO PT DURING PROCEDURE. ON (B)(6) 2024, (B)(6), A PHYSICIAN'S ASSISTANT, WITH (B)(6), REPORTED A DEVICE MALFUNCTION PERTAINING TO THE ACCUVEIN AV400 VEIN VISUALIZATION SYSTEM POWERED WHEELED STAND. THE MALFUNCTION OCCURRED DURING AN INJECTABLE FILLER PROCEDURE. (B)(6), PA, WAS PERFORMING THE PROCEDURE. (B)(6) WAS USING THE HF470 STAND TO POSITION THE AV400 VEIN VISUALIZATION SYSTEM SCANNER OVER THE PATIENT'S FACE. THE TOP-PART ARM OF THE STAND SNAPPED OFF WHERE IT MEETS THE POLE AND FELL ONTO THE PATIENT. THE NEEDLE WAS INSERTED INTO THE PATIENT DURING THE INCIDENT. THERE WAS NO VISIBLE INJURY TO THE PATIENT (NO BRUISING OR CUTS), BUT THE PATIENT WAS INFORMED TO ROONITOR THE SITE. NO PATIENT OR HEALTH CARE PROVIDER (HCP) INJURIES WERE REPORTED. ON (B)(6) 2024 UPDATED NOTES· CALL WITH (B)(6): NEEDLE WAS IN THE PATIENTS FACE WHEN THE HF470 ARM SNAPPED OFF. THE HF470 ARM FELL ON THE PATIENT'S LEGS (NOT HER FACE). AFTER THE ARM FELL, (B)(6) STOPPED THE PROCEDURE, REMOVED THE NEEDLE FROM THE PATIENT, GOT A DIFFERENT ACCUVEIN/STAND AND CONTINUED WITH THE PROCEDURE. NO VISIBLE INJURY TO THE PATIENTS' LEGS PRIOR TO LEAVING THE FACILITY. NO PHOTOS OF THE PATIENT WERE AVAILABLE. PHOTOS OF THE BROKEN ARM ARE AVAILABLE AND WERE PROVIDED BY (B)(6) WHEN REPORTED TO US. NURSES REQUESTED PATIENT MONITOR FOR INJURY FROM THE STAND AND INJURY FROM THE PROCEDURE IF UNEXPECTED SIDE-AFFECTS/SYMPTOMS OCCUR IN THE CORNING WEEK. PATIENT HAD NO CONCERN OF INJURY FROM THE ARM STRIKING HER LEGS, AND (B)(6) NOTED THAT PATIENT WAS VERY UNDERSTANDING AND WAS NOT UPSET ABOUT THE SITUATION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2150434 ACCUVEIN VEIN VISUALIZATION SYSTEM POWERED WHEELED STAND DEVICE, VEIN LOCATION, LIQUID CRYSTAL KZA ACCUVEIN INC. HF470 HF18300001-18300204

Patients

Seq Age Sex Outcome Treatment
1 29 YR Female ACCUVEIN AV470