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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER INTRAVASCULAR CATHETER
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BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 393222
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/23/2019
Event Type  malfunction  
Manufacturer Narrative
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 during use the cannula will not flush with a bd venflon¿ pro safety shielded iv catheter. The following information was provided by the initial reporter: the cannula will not flush through the blue part on the top. Can only flush through the white part.
 
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Brand NameBD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer (Section G)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key9180817
MDR Text Key170290117
Report Number8041187-2019-00811
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number393222
Device Lot Number9164761
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 Received09/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/13/2019
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: 10/11/2019 Patient Sequence Number: 1
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