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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 383536
Device Problems Difficult to Insert (1316); Difficult to Remove (1528)
Patient Problem Insufficient Information (4580)
Event Date 02/14/2021
Event Type  malfunction  
Event Description
This occured after the iv was inserted when trying to separate the needle from the iv clave as we do when we start the iv, get flash, and advance the catheter from the needle. After insertion into the vein the iv would not separate from the needle. (could not pull the needle back & insert catheter)- whole device was removed from patient and another iv catheter inserted.
 
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Brand NameBD NEXIVA, BD Q-SYTE
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
1 becton drive
franklin lakes NJ 07417
MDR Report Key11515521
MDR Text Key240635016
Report Number11515521
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 Risk Manager
Type of Report Initial
Report Date 02/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number383536
Device Catalogue Number383536
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/16/2021
Event Location Hospital
Date Report to Manufacturer03/18/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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