• 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 YEL 24GA IV CANNULA INTERVASCULAR 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 YEL 24GA IV CANNULA INTERVASCULAR CATHETER Back to Search Results
Catalog Number 391350
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Tissue Damage (2104)
Event Date 06/05/2019
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. (b)(6). There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 8109407, medical device expiration date: 2023-04-30, device manufacture date: 2018-04-19. Medical device lot #: 8052236, medical device expiration date: 2023-02-28, device manufacture date: 2018-03-15. Medical device lot #: 7354447, medical device expiration date: 2022-12-31, device manufacture date: 2018-02-08. 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 an unspecified number of neoflon yel 24ga iv cannulas caused medical intervention in the form of a bolus dosage due to a delay in treatment caused by an inability to apply the catheter. The incident took place during use of the device. The following information was provided by the initial reporter: the last year customer reported a complaint regarding neoflon - purple and yellow. Recently they were experiencing the same problem. Catheter peels back and therefore neonate had to be punctured several times. Later start with fluid/medication. Sometimes a higher dosage to make up for lost time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNEOFLON YEL 24GA IV CANNULA
Type of DeviceINTERVASCULAR 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 Key8729075
MDR Text Key149702780
Report Number8041187-2019-00485
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeNL
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 07/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number391350
Device Lot NumberSEE H.10
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 Received06/05/2019
Was Device Evaluated by Manufacturer? Yes
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: 06/24/2019 Patient Sequence Number: 1
-
-