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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON VENFLON I 20GA 1.0 MM X 32MM INTRAVASCULAR CATHETER

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BECTON DICKINSON VENFLON I 20GA 1.0 MM X 32MM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 391592
Device Problem Degraded (1153)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/12/2019
Event Type  malfunction  
Manufacturer Narrative
The manufacturing location for this product is (b)(4). This site is not registered with the fda. Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation and/or device history review, a supplemental report will be filed.
 
Event Description
It was reported that before use of the venflon i 20ga 1. 0 mm x 32mm there "rusting on the stillet. " the following information was provided by the initial reporter: "there is rusting on stillet. ".
 
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Brand NameVENFLON I 20GA 1.0 MM X 32MM
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8492462
MDR Text Key147345955
Report Number2243072-2019-00678
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number391592
Device Lot Number8331568
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 Received03/15/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/27/2018
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: 04/08/2019 Patient Sequence Number: 1
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