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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD VENFLON PRO SAFETY 14 CATHETER

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BECTON DICKINSON UNSPECIFIED BD VENFLON PRO SAFETY 14 CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problem Leak/Splash (1354)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/03/2021
Event Type  malfunction  
Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured. A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured. Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number. Medical device expiration date: unknown. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that unspecified bd venflon pro safety 14 separated and leaked. The following information was provided by the initial reporter: patient undergoing total intravenous anaesthesia (tiva) with propofol and remifentanil for craniotomy via 14 guage cannula sited in l saphenous vein. 2 hours into the anaesthetic bolus of glycopyrrolate given to treat bradycardia. Glycopyrrolate given via hub of 14g cannula. Couple of minutes later patients heart rate, blood pressure and bispectral index started increasing. Cannula checked and noted to be leaking the propofol and remifentanil out of the hub. Hub occluded with syringe, and bolus of propofol given via alternative cannula. On further inspection the grey valve mechanism under the cannula hub had moved so that it was no longer effective. Details of injury (to patient, carer or healthcare professional): potential risk of accidental awareness under general anaesthesia (aaga) due to failure of delivery of total intravenous anaesthesia (tiva). Action taken (includes any action by patient, carer or healthcare professional, or by the manufacturer or supplier): failure of cannula and anaesthetic delivery noticed promptly, bolus of iv anaesthetic (propofol) given via already sited back-up cannula to maintain anaesthesia. New cannula sited in alternative vein. Tiva switched from defective cannula to newly sited cannula.
 
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Brand NameUNSPECIFIED BD VENFLON PRO SAFETY 14
Type of DeviceCATHETER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11606235
MDR Text Key243584325
Report Number2243072-2021-00919
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
UNKNOWN
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 05/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/28/2021
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 Initial

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