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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD VENFLON IV CANNULA 20G INTERVASCULAR CATHETER

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BECTON DICKINSON BD VENFLON IV CANNULA 20G INTERVASCULAR CATHETER Back to Search Results
Catalog Number 391592
Device Problem Material Split, Cut or Torn (4008)
Patient Problem Phlebitis (2004)
Event Date 02/19/2022
Event Type  Injury  
Manufacturer Narrative
The manufacturing location for this product is (b)(4). This site is an oem manufacturing site. 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 sample is available for evaluation. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported while using bd venflon iv cannula 20g the needle went through the catheter during use. This led to an increased duration for patient's stay in hospital. There was no report of patient impact. The following information was provided by the initial reporter: when drs tries to increase catheter went down.
 
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Brand NameBD VENFLON IV CANNULA 20G
Type of DeviceINTERVASCULAR 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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13659167
MDR Text Key286950256
Report Number2243072-2022-00300
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number391592
Device Lot Number1148772
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/28/2021
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: 03/03/2022 Patient Sequence Number: 1
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