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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 383539
Device Problem Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/28/2019
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that bd nexiva¿ closed iv catheter system had a safety shield failure. This occurred on 2 separate occasions. No serious injury or medical intervention was reported. The following information was provided by the initial reporter: material no: 383539, batch no: 9029871. It was reported that "there is resistance and almost a grinding sound wen separating the hub". Per description: feeling resistance and almost a grinding sound when separating the hub. It's almost as if there's a lack of lubricant on the needle piece that the hub slides over. Staff are hearing and feeling the issue when they are doing the first twist to break the seal before inserting into patient.
 
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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 Key8565433
MDR Text Key145113907
Report Number1710034-2019-00469
Device Sequence Number1
Product Code FOZ
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 other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 06/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/31/2021
Device Catalogue Number383539
Device Lot Number9029871
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/24/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/15/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/29/2019
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: 04/30/2019 Patient Sequence Number: 1
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