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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD VENFLON¿ PERIPHERAL PORTED IV CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON BD VENFLON¿ PERIPHERAL PORTED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 391452
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/09/2022
Event Type  malfunction  
Event Description
It was reported while using bd venflon¿ peripheral ported iv catheter the port cap is deformed. There was no report of patient impact. The following information was provided by the initial reporter: the blue lid is slanted, and cannot be turned, therefore it is not suitable for fixing.
 
Manufacturer Narrative
The manufacturing location for this product is (b)(6). This site is an oem manufacturing site. Therefore, bd corporate headquarters in (b)(4) has been listed. , and (b)(4) fda registration number has been used for the manufacture report number. A device evaluation and/or device history review is anticipated but is not complete. Upon completion, a supplemental report will be filed.
 
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Brand NameBD VENFLON¿ PERIPHERAL PORTED IV CATHETER
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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key14622817
MDR Text Key294135725
Report Number2243072-2022-00766
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeSZ
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 06/15/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number391452
Device Lot Number1162921
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/11/2021
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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