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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) VENFLON PRO SAFETY 14GA 2.0MM OD 45MM L CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) VENFLON PRO SAFETY 14GA 2.0MM OD 45MM L CATHETER Back to Search Results
Catalog Number 393230
Device Problem Leak/Splash (1354)
Patient Problem Blood Loss (2597)
Event Date 11/18/2020
Event Type  malfunction  
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 14ga 2. 0mm od 45mm l leaked. The following information was provided by the initial reporter: i have just been informed we have a massive problem with bd pro-safety (14 and 16 g) in our theatres. As you can see from the photographs both blood and fluids are leaking from the port. This is happening cross site (sth and guys), with multiple lot numbers involved and they are present in 15 omnicell cabinets. It will be difficult to sequester the offending items but i have copied both tarvinder and greg for their assistance on how best to manage this situation,. The mrha has been notified. I cannot stress the urgency of this situation.
 
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Brand NameVENFLON PRO SAFETY 14GA 2.0MM OD 45MM 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 Key11009485
MDR Text Key222021620
Report Number8041187-2020-00832
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,Followup
Report Date 01/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number393230
Device Lot NumberSEE H.10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/20/2020
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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