• 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 VENFLON PRO SAFETY SAFETY VENOUS INDWELLING CATHETER INTRAVASCUALR 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 VENFLON PRO SAFETY SAFETY VENOUS INDWELLING CATHETER INTRAVASCUALR CATHETER Back to Search Results
Catalog Number 393224
Device Problems Break (1069); Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/07/2022
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported while using bd venflon pro safety venous indwelling catheter the catheter separated from the hub and remained in patient's arm. The following information was provided by the initial reporter: we hereby report an incident which occurred on or around 07/06. Defective material, a piece of material was found left in the patient's arm. There were no special complications with this patient, such as agitation. Upon inspection, it appeared that a piece of the plastic cannula was missing when the venipuncture was removed. Reported to the direction of the registrar, um, assistant physician, neurologist, vascular surgeon in the icu who decided to perform an arm ultrasound and possibly a ct scan.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD VENFLON PRO SAFETY SAFETY VENOUS INDWELLING CATHETER
Type of DeviceINTRAVASCUALR 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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15005563
MDR Text Key295860907
Report Number8041187-2022-00365
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number393224
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/28/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/13/2022 Patient Sequence Number: 1
-
-