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U.S. Department of Health and Human Services

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

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BECTON, DICKINSON AND COMPANY BD NEXIVA DIFFUSICS CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 383592
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/08/2018
Event Type  malfunction  
Event Description
Diffusics catheter failure. Nurse placed d iv prior to procedure, just secured device attempted to attach 10 cc syringe to flush device and tubing broke off from the device. Nurse immediately pulled the catheter. No harm to patient.
 
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Brand NameBD NEXIVA DIFFUSICS
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
9450 south state street
sandy UT 84070
MDR Report Key7595612
MDR Text Key110874839
Report Number7595612
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 06/05/2018,06/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2020
Device Model Number383592
Device Catalogue NumberNOT AVAILABLE
Device Lot Number7326874
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/05/2018
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer06/05/2018
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

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