• 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 MEDICAL (SINGAPORE) BD NEOFLON¿ IV CANNULA, 26 G X 19 MM 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 MEDICAL (SINGAPORE) BD NEOFLON¿ IV CANNULA, 26 G X 19 MM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 391349
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/15/2017
Event Type  Injury  
Manufacturer Narrative
Investigation: investigation summary: one representative sample was returned for investigation. The samples were subjected to visual inspection. Peel back was not observed on the representative samples. Peel back was not observed on the returned sample photo. Catheter bevel angle and catheter tip od measurement had performed on the representative sample and the result met the product specification. Dhr review - no complain related qn and deviations is raised on the involved batch. Investigation conclusion: bevel angle and tip od measurement of the representative sample were within specification. Root cause description: not able to determine.
 
Event Description
It was reported that the catheter on a bd neoflon¿ iv cannula, 26 g x 19 mm escalated during insertion requiring child to be moved to a different hospital.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD NEOFLON¿ IV CANNULA, 26 G X 19 MM
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer (Section G)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key6984291
MDR Text Key90456248
Report Number8041187-2017-00135
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K850276
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial
Report Date 10/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date04/30/2022
Device Catalogue Number391349
Device Lot Number7138128
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/09/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/02/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/08/2017
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: 10/27/2017 Patient Sequence Number: 1
-
-