• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEXUS MEDICAL, LLC NEEDLE BLUNTLESS CANNULA / CANNULA BLUNT TIP SET, ADMINISTRATION, INTRAVASCULAR

  • 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
 

NEXUS MEDICAL, LLC NEEDLE BLUNTLESS CANNULA / CANNULA BLUNT TIP SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N0657
Device Problems Fluid Leak (1250); Product Quality Problem (1506); Material Integrity Problem (2978)
Patient Problem Insufficient Information (4580)
Event Date 07/26/2021
Event Type  malfunction  
Event Description
The needleless blunt cannula is ineffective at puncturing the rubberized covering of the medicine vial. The rubber covering pushed into the medicine vial, causing the medicine to spill. Fda safety report id # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNEEDLE BLUNTLESS CANNULA / CANNULA BLUNT TIP
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
NEXUS MEDICAL, LLC
MDR Report Key12460536
MDR Text Key271462843
Report NumberMW5103861
Device Sequence Number1
Product Code FPA
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/08/2021
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
Device Model NumberN0657
Device Lot Number21089
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-