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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD VENFLON¿ IV CATHETERS INTERVASCULAR CATHETER

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BECTON DICKINSON BD VENFLON¿ IV CATHETERS INTERVASCULAR CATHETER Back to Search Results
Catalog Number 391453
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem Hematoma (1884)
Event Date 09/13/2021
Event Type  malfunction  
Manufacturer Narrative
Oem manufacture: the manufacturing location for this product is (b)(4). This site is an oem manufacturing site. (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 at least 5 bd venflon¿ iv catheters experienced catheter splitting. The following information was provided by the initial reporter: 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 CATHETERS
Type of DeviceINTERVASCULAR 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 Key12666244
MDR Text Key277433797
Report Number2243072-2021-02541
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,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,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 Manufacturer10/28/2021
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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