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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRANSLITE LLC VEINLITE NEO; LIGHT, EXAMINATION, MEDICAL, BATTERY POWERED
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TRANSLITE LLC VEINLITE NEO; LIGHT, EXAMINATION, MEDICAL, BATTERY POWERED Back to Search Results
Device Problem Unexpected Shutdown (4019)
Patient Problems Partial thickness (Second Degree) Burn (2694); Blister (4537)
Event Date 05/29/2023
Event Type  malfunction  
Event Description
Provider was attempting arterial stick in the left radial artery with the assistance of rn.Provider used a small light, to visualize artery, while attempting art stick.The light was held against the dorsal aspect of the pt's left wrist.The light was removed and replaced several times throughout the procedure because it kept turning off.After procedure was completed, rn saw that the patient had a large round burn to the dorsal aspect of their wrist.The burned area was white and raised with a small semicircular erythemic blister.Provider was notified and came to assess the burn site.Manufacturer response for vein finder, veinlite neo (per site reporter).
 
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Brand Name
VEINLITE NEO
Type of Device
LIGHT, EXAMINATION, MEDICAL, BATTERY POWERED
Manufacturer (Section D)
TRANSLITE LLC
345 commerce green blvd
sugar land TX 77478
MDR Report Key17253932
MDR Text Key318358907
Report Number17253932
Device Sequence Number1
Product Code KYT
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 06/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/19/2023
Event Location Hospital
Date Report to Manufacturer07/05/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age1 DA
Patient SexMale
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