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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD NEXIVA CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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BECTON, DICKINSON AND COMPANY BD NEXIVA CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 383516
Device Problems Break (1069); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/04/2022
Event Type  malfunction  
Event Description
Piv catheter shredded inside of patients vein while placing it. Piv placed from emergency medical services (ems) also kinked multiple times.
 
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Brand NameBD NEXIVA
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 Key13558803
MDR Text Key285819025
Report Number13558803
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903835165
UDI-Public(01)30382903835165
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 02/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number383516
Device Catalogue Number383516
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 FDA02/04/2022
Event Location Hospital
Date Report to Manufacturer02/18/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Unkown

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