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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY IV CATHETER 20G INTRAVENEOUS CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY IV CATHETER 20G INTRAVENEOUS CATHETER Back to Search Results
Catalog Number 393264
Device Problem Insufficient Information (3190)
Patient Problem Phlebitis (2004)
Event Date 02/12/2016
Event Type  Injury  
Manufacturer Narrative
The date of event is unknown. The date received by the manufacturer is used. Suspect medical device; device manufacture date: the exact device used in this incident is unknown. Two potential lot numbers have been provided for the reported catalog number. Lot 5265426, medical device expiration date: 9/30/2018, device manufacture date: 9/22/2015; lot 5030237, medical device expiration date: 1/31/2018, device manufacture date: 1/30/2015. Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us.
 
Event Description
It was reported that at (b)(6), the patient had surgery following phlebitis from the suspect device. Although it is unknown who placed and operated the device, it was reported that the rescue service at the facility places 50% of the vascular access devices.
 
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Brand NameBD VENFLON¿ PRO SAFETY IV CATHETER 20G
Type of DeviceINTRAVENEOUS 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
8015652845
MDR Report Key5495044
MDR Text Key40158990
Report Number8041187-2016-00016
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial
Report Date 03/11/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue Number393264
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/12/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/11/2016 Patient Sequence Number: 1
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