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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEXIVA 24 GA X 3/4 IN SINGLE PORT INTRAVASCULAR CATHETER

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NEXIVA 24 GA X 3/4 IN SINGLE PORT INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383511
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/30/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that nexiva 24 ga x 3/4 in single port needle was loose. This occurred on 6 occasions. The following information was provided by the initial reporter: it happened in the transfusion room of pediatric outpatient department. When nurse opened the indwelling needle, the needle became loose and felt very astringent. It was suspected that there were impurities or rust inside.
 
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Brand NameNEXIVA 24 GA X 3/4 IN SINGLE PORT
Type of DeviceINTRAVASCULAR CATHETER
MDR Report Key12021640
MDR Text Key260760619
Report Number1710034-2021-00508
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K183399
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 07/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383511
Device Lot Number0163980
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/11/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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