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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEXIVA 22GA X 1.00 IN DP WITH MAXZERO INTRAVASCULAR CATHETER

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NEXIVA 22GA X 1.00 IN DP WITH MAXZERO INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383572
Device Problem Flushing Problem (1252)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/12/2021
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 22ga x 1. 00 in dp with maxzero had incomplete flush. The following information was provided by the initial reporter: it is reported customer is experiencing leakage. Maxzero ivs that we are using do not allow us to connect and disconnect without having drips of fluid on them. I have tightened them but when we disconnect from the hub, there are still drips of liquid. We are using radioactive material for this. Also the sponge part of the hub, the activity is getting hung up in there. We have to flush it profusely.
 
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Brand NameNEXIVA 22GA X 1.00 IN DP WITH MAXZERO
Type of DeviceINTRAVASCULAR CATHETER
MDR Report Key12452923
MDR Text Key270801536
Report Number9610847-2021-00430
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 other,user facility
Type of Report Initial,Followup
Report Date 09/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383572
Device Lot Number0206528
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/03/2020
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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