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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD NEXIVA, BD Q-SYTE; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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BECTON, DICKINSON AND COMPANY BD NEXIVA, BD Q-SYTE; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 383539
Device Problems Leak/Splash (1354); Defective Device (2588)
Patient Problem Insufficient Information (4580)
Event Date 06/12/2021
Event Type  malfunction  
Event Description
Started a new iv on patient.After iv was inserted and needle retracted completely, iv began to leak from where the needle was removed.Had to remove faulty iv and poke patient again.The leak happened right after i inserted the iv and retracted the needle out.There was a little rubber-looking stopper on the end of the green triangle part that was the part that was leaking.At first i was not sure if the blood was coming from the iv itself or the insertion site so i flushed with saline and saline squirted out of that spot there.
 
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Brand Name
BD NEXIVA, BD Q-SYTE
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
1 becton drive
franklin lakes NJ 07417
MDR Report Key12106499
MDR Text Key259611075
Report Number12106499
Device Sequence Number1
Product Code FOZ
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 06/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number383539
Device Catalogue Number383539
Device Lot Number1011066
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/30/2021
Event Location Hospital
Date Report to Manufacturer07/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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