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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) VENFLON PRO SAFETY 20GA 1.1MM OD 32MM L CATHETER
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BECTON DICKINSON MEDICAL (SINGAPORE) VENFLON PRO SAFETY 20GA 1.1MM OD 32MM L CATHETER Back to Search Results
Catalog Number 393224
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)
Event Date 10/04/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that venflon pro safety 20ga 1. 1mm od 32mm l catheter broke. The following information was provided by the initial reporter: problems with iv, burr and elevations in cannula (catheter). Pieces come loose in the blood vessel, this is very dangerous.
 
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Brand NameVENFLON PRO SAFETY 20GA 1.1MM OD 32MM L
Type of DeviceCATHETER
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12738335
MDR Text Key279647059
Report Number8041187-2021-00941
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeNL
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 11/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number393224
Device Lot Number1175160
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/19/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/04/2021
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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