• 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 INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM 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 INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383532
Device Problems Detachment Of Device Component (1104); Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/11/2018
Event Type  malfunction  
Manufacturer Narrative
Initial reporter email: (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 when inserting the bd nexiva¿ closed iv catheter system, the needle did not detach from the iv line once inserted. It retracted fully but remained stuck. We ended up having to remove the (successful) iv we had just inserted because we physically couldn¿t get the needle detached. Once the iv line was out of the patient, it took great force/pulling to actually detach the needle. Found during use. No reports of serious injury or medical intervention noted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD NEXIVA¿ CLOSED IV CATHETER SYSTEM
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer (Section G)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7602171
MDR Text Key111678202
Report Number1710034-2018-00318
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K161777
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date09/30/2020
Device Catalogue Number383532
Device Lot Number7290663
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/17/2017
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: 06/14/2018 Patient Sequence Number: 1
-
-