• 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 CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY 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 CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY INTRAVASCULAR CATHETER Back to Search Results
Model Number 386865
Device Problems Leak/Splash (1354); Retraction Problem (1536)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/09/2021
Event Type  malfunction  
Manufacturer Narrative
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 the blood control safety feature on the bd cathena¿ safety iv catheter with bd multiguard¿ technology failed to allow the needle to disengage after it was inserted into the patient's vein. The following information was provided by the initial reporter: "wanted to let you know of an issue we're having with the 18 gauge cathena iv's. The needle will not disengage when the plastic catheter is inserted in the vein. It was stuck yesterday while in the the patient's vein. When we able to get the needle out, the metal was bent. Today an 18 gauge iv was stuck again when trying to insert the plastic catheter and disengage the metal needle. " "there were 3 needles used on patients and discovered to be damaged that i am aware of. ".
 
Manufacturer Narrative
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 the blood control safety feature on the bd cathena¿ safety iv catheter with bd multiguard¿ technology failed to allow the needle to disengage after it was inserted into the patient's vein. The following information was provided by the initial reporter: "wanted to let you know of an issue we're having with the 18 gauge cathena iv's. The needle will not disengage when the plastic catheter is inserted in the vein. It was stuck yesterday while in the the patient's vein. When we able to get the needle out, the metal was bent. Today an 18 gauge iv was stuck again when trying to insert the plastic catheter and disengage the metal needle. " "there were 3 needles used on patients and discovered to be damaged that i am aware of. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY
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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12968243
MDR Text Key285558924
Report Number8041187-2021-01036
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201717
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/12/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number386865
Device Catalogue Number386865
Device Lot Number1144979
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/24/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-