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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 Problem Material Protrusion/Extrusion (2979)
Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Event Date 01/17/2021
Event Type  Injury  
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).
 
Event Description
It was reported that venflon pro safety 20ga 1. 1mm od 32mm l safety mechanism broke and caused a needle stick injury. The following information was provided by the initial reporter: needle stick injury sustained by ed reg cannulating under ultrasound guidance using bd venflon or safety cannula 20g. Ed spr reported that the safety end fell off as the needle was removed from patient. This shouldn't happen. Realized after needle stick that the safety hand was lying in the cannulation tray having fallen/broken off. Also second incident relating to same event pathology lab failed to run the donor patients blood sample overnight. This had to be chased by ed in the morning and the donor sample is positive for (b)(6). Action taken at the time of the incident: all 20g cannulas in ed of the same lot number have been quarantined and will be returned to procurement for checking unsure if they are faulty or it was user error.
 
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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
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11317325
MDR Text Key234232285
Report Number8041187-2021-00094
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 05/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number393224
Device Lot Number0171013
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/19/2020
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: 02/11/2021 Patient Sequence Number: 1
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