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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNSPECIFIED BD¿ VENFLON PRO CATHETER

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UNSPECIFIED BD¿ VENFLON PRO CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Hypersensitivity/Allergic reaction (1907); Phlebitis (2004); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/21/2021
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured. A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured. Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number. Medical device expiration date: unknown. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that unspecified bd¿ venflon pro was used and the clinicians experienced an infection on 10 occasions. The following information was provided by the initial reporter: it was reported via post market survey that clinicians encountered cannula related bloodstream infection (e. G. Blood stream bacteraemia, sepsis) (10), phlebitis (70), infiltration (80), extravasation (not related to high pressure injection of contrast media) (80), extravasation with high pressure injection of contrast media (30) and cannula occlusion (102).
 
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Brand NameUNSPECIFIED BD¿ VENFLON PRO
Type of DeviceCATHETER
MDR Report Key12666738
MDR Text Key277484500
Report Number2243072-2021-02542
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial
Report Date 09/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2021
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

Patient Treatment Data
Date Received: 10/20/2021 Patient Sequence Number: 1
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