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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VENFLON I 18GA 1.2 MM X 45MM CATHETER

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VENFLON I 18GA 1.2 MM X 45MM CATHETER Back to Search Results
Catalog Number 391593
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/23/2021
Event Type  malfunction  
Manufacturer Narrative
The manufacturing location for this product is (b)(4). This site is not registered with the fda. Therefore, bd corporate headquarters in franklin lakes, nj has been listed and the (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.
Event Description
It was reported that venflon i 18ga 1. 2 mm x 45mm came with a mix of product types. This occurred on 500 occasions. The following information was provided by the initial reporter: when distributor open a double tapping sealed cartoon of venflon i-18g, he found 500 units of venflon i 22g inside the cartoon then he call me to check the material on sport. There is no damage and other incident only mismatch of cannula gauze.
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Brand NameVENFLON I 18GA 1.2 MM X 45MM
Type of DeviceCATHETER
MDR Report Key12351065
MDR Text Key267675132
Report Number2243072-2021-02136
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 09/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number391593
Device Lot Number0361920
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2021
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