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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNSPECIFIED BD NEOFLON¿ IV CANNULA INTRAVASCULAR CATHETER

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UNSPECIFIED BD NEOFLON¿ IV CANNULA INTRAVASCULAR CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Date 09/21/2021
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used as a default. Medical device expiration date: unknown. Device manufacture date: unknown. As no physical sample, part number or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed. Based on the limited investigation results, a cause for the reported incident could not be determined. Examination of the product involved may provide clarification as to the cause for the reported failure. Complaints received for this device and reported condition will continue to be tracked and trended. Our quality team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that while using unspecified bd neoflon¿ iv cannula, 4 patients got infections that required medical intervention. 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). ".
 
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Brand NameUNSPECIFIED BD NEOFLON¿ IV CANNULA
Type of DeviceINTRAVASCULAR CATHETER
MDR Report Key12667853
MDR Text Key278427146
Report Number2243072-2021-02554
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
Type of Report Initial
Report Date 10/01/2021
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 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 Received09/27/2021
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

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