Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 AND COMPANY NEXIVA; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
  • 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 AND COMPANY NEXIVA; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 383516, 383591
Patient Problems Failure of Implant (1924); Needle Stick/Puncture (2462)
Event Date 06/29/2023
Event Type  malfunction  
Event Description
During iv placement of 2 different size catheters and at least 2 different patients (#20 piv and #22 piv) the catheter would not advance after getting a flash.When the rn pulled the catheter out after the attempt the actual plastic catheter that typically sits within the vein was compromised/split.This was reported out as the daily safety huddle in the ed, no further details (i.E.Lot #s) can be obtained.Catheters were discarded.One instance was on a child, the other on an adult.A summary of the events were sent to the bd rep.Manufacturer response for peripheral iv set, nexiva (20 ga x 1in and 22 ga x1in) (per site reporter).Escalated events to mfg rep directly to discuss possible practice elements that could have contributed.This was ruled out.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NEXIVA
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
1 becton dr
franklin lakes NJ 07417
MDR Report Key17497494
MDR Text Key320768841
Report Number17497494
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 07/14/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number383516, 383591
Device Catalogue Number383516, 383591
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/14/2023
Event Location Hospital
Date Report to Manufacturer08/10/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/10/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-