• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON 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. Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported while using unspecified bd neoflon¿ iv cannula, 16 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) (16)".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNSPECIFIED BD NEOFLON¿ IV CANNULA
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key12674370
MDR Text Key277720543
Report Number2243072-2021-02565
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
1 Patient was Involved in the Event
Date FDA Received10/21/2021
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: 10/21/2021 Patient Sequence Number: 1
-
-