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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA DUAL PORT 22GA 1.00IN (0.9 MM X 25 MM) INTERVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA DUAL PORT 22GA 1.00IN (0.9 MM X 25 MM) INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383532
Device Problems Retraction Problem (1536); Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/02/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the bd nexiva dual port 22ga 1. 00in (0. 9 mm x 25 mm) experienced a retraction issue. The following information was provided by the initial reporter: material no. : 383532, batch no. : 8325685. It was reported that the device malfunctioned. It was clarified that the needle bent and did not retract all the way. Per email: requested action/disposition 2nd device to malfunction, same lot#. The first incident was a few days before the 2nd incident. Different patient, different staff member.
 
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Brand NameBD NEXIVA DUAL PORT 22GA 1.00IN (0.9 MM X 25 MM)
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 Key8528579
MDR Text Key142484085
Report Number1710034-2019-00431
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161777
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
Report Date 05/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/31/2021
Device Catalogue Number383532
Device Lot Number8325685
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 Received04/02/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/21/2018
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: 04/18/2019 Patient Sequence Number: 1
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