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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. BD NEXIVA IV START KIT CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. BD NEXIVA IV START KIT CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 383519
Device Problems Break (1069); Detachment Of Device Component (1104); Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/12/2018
Event Type  Injury  
Event Description
Anesthesia inserting peripheral iv catheter and tubing broke off from the cannula leaving needle and cannula separated. Catheter was removed and no harm to pt.
 
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Brand NameBD NEXIVA IV START KIT
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
sandy UT 84070
MDR Report Key7600627
MDR Text Key111198452
Report NumberMW5077852
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 Voluntary
Reporter Occupation
Type of Report Initial
Report Date 06/12/2018
1 Device was Involved in the Event
1 Patient was 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 Number383519
Device Lot Number7339690
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/13/2018 Patient Sequence Number: 1
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