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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD VENFLON¿ IV CANNULA WITH FEP POLYMER INTRAVASCULAR CATHETER

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BECTON DICKINSON BD VENFLON¿ IV CANNULA WITH FEP POLYMER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 391453
Device Problem Material Split, Cut or Torn (4008)
Patient Problem Hematoma (1884)
Event Date 09/16/2021
Event Type  malfunction  
Manufacturer Narrative
The manufacturing location for this product is (b)(4). This site is not registered with the fda. (b)(4). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the bd venflon¿ iv cannula with fep polymer split once the cannula was removed. This occurred 5 separate times during use. This complaint was created to capture the 3rd of 3 related incidents. The following information was provided by the initial reporter, translated from (b)(6) to english: "during cannulation of the peripheral vein a bulge was formed just behind the puncture site which resulted in the discontinuity of the vessel. Then a subcutaneous hematoma developed. After immediate removal of the cannula, delamination of the plastic part was observed. This situation happened many times. ".
 
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Brand NameBD VENFLON¿ IV CANNULA WITH FEP POLYMER
Type of DeviceINTRAVASCULAR CATHETER
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 Key12668839
MDR Text Key278131690
Report Number2243072-2021-02561
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodePL
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 11/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number391453
Device Lot Number0304783
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/30/2020
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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