• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA¿ DIFFUSICS¿ 24G X 0.75 IN GLOBAL 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
 

BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA¿ DIFFUSICS¿ 24G X 0.75 IN GLOBAL INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383691
Device Problem Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/25/2019
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 safety mechanism failed and breaks during use with a bd nexiva¿ diffusics¿ 24g x 0. 75 in global. The following information was provided by the initial reporter: successfully inserted the cannula into the patients vein. While activating the safety device and removing the needle the needle became detached from the safety gray colored casing, which remained attached to the back end of the cannula. Disposed the needle into the sharps bin. Detached the gray colored part of the device from the back end of the cannula and noticed that there was a small piece of metal lying on the patients skin. We kept the gray colored piece and the piece of metal for return. The cannula itself, in the patients vein was ok for use, however there was a failure with the safety mechanism in this incident.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD NEXIVA¿ DIFFUSICS¿ 24G X 0.75 IN GLOBAL
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
Manufacturer (Section G)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8601245
MDR Text Key145947910
Report Number9610847-2019-00368
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K173354
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 07/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/30/2021
Device Catalogue Number383691
Device Lot Number8148838
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 Received04/25/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/31/2018
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: 05/10/2019 Patient Sequence Number: 1
-
-