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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383516
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/10/2019
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that bd nexiva¿ closed iv catheter system extension tubing blew up during use. The following information was provided by the initial reporter: material no. : 383516, batch no. : unknown. It was reported that the extension tubing blew up at both ends while in use. 20g catheter tubing blew up going 2. 5ml/sec and the injector was told to have been set at 300psi. Radiology has had an issue with a 20g nexiva iv cath. Both ends of the tubing ¿blew up¿. This product appears to be a nexiva catheter and not a nexiva diffusics.
 
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Brand NameBD NEXIVA¿ CLOSED IV CATHETER SYSTEM
Type of DeviceINTERVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer (Section G)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8740660
MDR Text Key149555977
Report Number1710034-2019-00684
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903835165
UDI-Public30382903835165
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K183399
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383516
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/27/2019 Patient Sequence Number: 1
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