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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 393226
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 11/13/2019
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation and/or device history review, a supplemental report will be filed.
 
Event Description
It was reported that during use of the bd venflon¿ pro safety shielded iv catheter when the catheter was removed a piece of cannula was located subcutaneously. Attempts were made to remove this through incision and failed. The following information was provided by the initial reporter, translated from (b)(6) to english: in the venflon pricking, the protocol was followed. When removing the venflon there was some resistance which caused a piece of the cannula to break off. The result is that a piece of cannula was left behind in the body. Attempts were made to remove this through incision and failed. Unfortunately the packaging was thrown away and the lot number is not known. Have you received multiple reports for this article? risks: as it was found that a piece of cannula was located subcutaneously, the risk in this case is not high. This would be different if the same thing had happened intravenously. However, the patient is burdened by follow-up examinations.
 
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Brand NameBD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER
Type of DeviceINTRAVASCULAR 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
8015652341
MDR Report Key9385158
MDR Text Key168287273
Report Number8041187-2019-00959
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
N/A
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 12/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2022
Device Catalogue Number393226
Device Lot Number9184024
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/03/2019
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: 11/27/2019 Patient Sequence Number: 1
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