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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 393229
Device Problem Leak/Splash (1354)
Patient Problem Blood Loss (2597)
Event Date 11/09/2020
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. (b)(4).
 
Event Description
It was reported that iv fluid and blood leaked from the bd venflon¿ pro safety peripheral safety iv catheter injection port during use. This complaint was created to capture the 2nd of 2 related incidents. The following information was provided by the initial reporter: (b)(6) 2020 16 g iv cannula valve failed with iv fluids and blood squirting up through the injectable access point''.
 
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Brand NameBD VENFLON PRO SAFETY PERIPHERAL SAFETY 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
8015296192
MDR Report Key10989189
MDR Text Key224792812
Report Number8041187-2020-00824
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
NA
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 12/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number393229
Device Lot Number0144807
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/22/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/23/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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