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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON VENFLON 2 BL 22GA IV CANNULA; INTRAVASCULAR CATHETER
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BECTON DICKINSON VENFLON 2 BL 22GA IV CANNULA; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 391451
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/27/2020
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.(b)(4).Oem manufacture: (b)(4).
 
Event Description
It was reported that venflon 2 bl 22ga iv cannula leaked.The following information was provided by the initial reporter: "cannula inserted successfully first pass.Introducer needle removed and end cap attached.Whilst securing to patient blood noted around hub.Cannula inspected and on removing cap from top-port blood noted to be freely flowing, so cap reclosed and cannula removed.Details of injury (to patient, carer or healthcare professional): none bar need for repeat cannulation.Action taken (includes any action by patient, carer or healthcare professional, or by the manufacturer or supplier) cannula removed and new cannula (different model) sited with no issues.".
 
Event Description
It was reported that venflon 2 bl 22ga iv cannula leaked.The following information was provided by the initial reporter: "cannula inserted successfully first pass.Introducer needle removed and end cap attached.Whilst securing to patient blood noted around hub.Cannula inspected and on removing cap from top-port blood noted to be freely flowing, so cap reclosed and cannula removed.Details of injury (to patient, carer or healthcare professional): none bar need for repeat cannulation.Action taken (includes any action by patient, carer or healthcare professional, or by the manufacturer or supplier) cannula removed and new cannula (different model) sited with no issues.".
 
Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the mdr 2243072-2020-02166 is a duplicate of 2243072-2020-02161 this supplemental is to cancel mdr 2243072-2020-02166.
 
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Brand Name
VENFLON 2 BL 22GA IV CANNULA
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key11072420
MDR Text Key224398909
Report Number2243072-2020-02166
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 01/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number391451
Device Lot Number9235103
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/30/2020
Initial Date FDA Received12/24/2020
Supplement Dates Manufacturer Received01/06/2021
Supplement Dates FDA Received01/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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