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: NEXIVA 20 GA X 1-1/4 IN SINGLE PORT; 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
 

NEXIVA 20 GA X 1-1/4 IN SINGLE PORT; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383517
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem Foreign Body Embolism (4439)
Event Date 06/04/2021
Event Type  Injury  
Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported that nexiva 20 ga x 1-1/4 in single port catheter broke.The following information was provided by the initial reporter: it was reported that nurse had difficulties removing catheter, once out, nurse noticed that the tip was missing.When ultrasound was ordered, it showed a piece of catheter beneath the skin.Tip was removed through unplanned outpatient procedure.Per complaint details received: iv was attempted in left ac with 20g closed iv system (bd 383517) obtained a flash back and attempted to advance catheter and vein blew.I pulled needle out without any difficulties.I then went to remove catheter and had difficulties once it got to the tip.I tried to move the patients arm and area around the catheter to try and remove it, the catheter came out but it was clearly missing the tip.The pa was notified and came in to assess the arm.Patient denied any pain in the arm.An ultrasound was ordered that showed a piece of the catheter beneath the skin surface.Vascular consulted and stated it can be removed in an outpatient setting.
 
Manufacturer Narrative
H6: investigation summary our quality engineer inspected the sample returned for evaluation.Bd received one physical sample without the packaging.Visual inspection of the device revealed that a portion of the catheter tubing was missing from the catheter tip.Magnified inspection of the damaged area led to the conclusion that the catheter tubing had been pierced by the needle tip due to the v-shaped cut observed, which is indicative of spear through.Other small cuts were observed at the end of the catheter tubing.This type of damage most likely contributed to separation of the catheter tubing tip.During the manufacturing process, spear through may result from the mandrel hitting the catheter during the tube flare process of production.It may also be a result of a gripper malfunction during manufacture, as a consequence of worn mandrels.This type of defect may also occur within the user environment if the clinician re-cannulates the needle during or before insertion.If the device was received with a needle piercing through the catheter tubing, venipuncture would be painful if not impossible.Based on the provided feedback regarding this incident, the investigative conclusions point towards an application related origin for the defect.As a lot number was unavailable for this incident, a review of the production records could not be completed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
 
Event Description
It was reported that nexiva 20 ga x 1-1/4 in single port catheter broke.The following information was provided by the initial reporter: it was reported that nurse had difficulties removing catheter, once out, nurse noticed that the tip was missing.When ultrasound was ordered, it showed a piece of catheter beneath the skin.Tip was removed through unplanned outpatient procedure.Per complaint details received: iv was attempted in left ac with 20g closed iv system (bd 383517) obtained a flash back and attempted to advance catheter and vein blew.I pulled needle out without any difficulties.I then went to remove catheter and had difficulties once it got to the tip.I tried to move the patients arm and area around the catheter to try and remove it, the catheter came out but it was clearly missing the tip.The pa was notified and came in to assess the arm.Patient denied any pain in the arm.An ultrasound was ordered that showed a piece of the catheter beneath the skin surface.Vascular consulted and stated it can be removed in an outpatient setting.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NEXIVA 20 GA X 1-1/4 IN SINGLE PORT
Type of Device
INTRAVASCULAR CATHETER
MDR Report Key12147376
MDR Text Key262304867
Report Number1710034-2021-00567
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903835171
UDI-Public00382903835171
Combination Product (y/n)N
PMA/PMN Number
K183399
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 08/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383517
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/18/2021
Initial Date Manufacturer Received 06/10/2021
Initial Date FDA Received07/09/2021
Supplement Dates Manufacturer Received08/04/2021
Supplement Dates FDA Received08/16/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-