• 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) NEOFLON 26GA 0.6MM OD 19MM L INDIA IV 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) NEOFLON 26GA 0.6MM OD 19MM L INDIA IV CATHETER Back to Search Results
Catalog Number 391359
Device Problems Material Puncture/Hole (1504); Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/01/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that ten neoflon 26ga 0. 6mm od 19mm l india experienced a defect with the cannula of the device malfunctioning. The following information was provided by the initial reporter: catheter tip of the cannula got punctured / burst during first insertion into patients' vein.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNEOFLON 26GA 0.6MM OD 19MM L INDIA
Type of DeviceIV 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
8015652341
MDR Report Key8519482
MDR Text Key145665281
Report Number8041187-2019-00307
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number391359
Device Lot Number7354023
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/01/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/12/2018
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: 04/16/2019 Patient Sequence Number: 1
-
-