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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACCUVEIN INC. ACCU VEIN; DEVICE, VEIN LOCATION, LIQUID CRYSTAL
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ACCUVEIN INC. ACCU VEIN; DEVICE, VEIN LOCATION, LIQUID CRYSTAL Back to Search Results
Model Number AV500
Device Problem Battery Problem (2885)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/11/2019
Event Type  malfunction  
Event Description
No patient harm.No patient incident.Poor design.Poor serviceability.Hand held accuvein device was put into service and failed three months later due to a bad battery.After speaking with the company, they said we needed to send the device in for repair.There is also a safety/security screw on the device that makes it more difficult to replace the battery.The battery is proprietary which further makes it difficult to repair the device.These issues lead to extended downtime and therefore unavailable for patient use - which could affect clinical workflow.Manufacturer response for vein finder, accuvein (per site reporter).Sending device today (day of report).More information to come.
 
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Brand Name
ACCU VEIN
Type of Device
DEVICE, VEIN LOCATION, LIQUID CRYSTAL
Manufacturer (Section D)
ACCUVEIN INC.
3243 route 112
building 1, suite 2
medford NY 11763
MDR Report Key9382869
MDR Text Key168231391
Report Number9382869
Device Sequence Number1
Product Code KZA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberAV500
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/18/2019
Device Age3 MO
Event Location Hospital
Date Report to Manufacturer11/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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