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

Model Number N0657

Device Problems Fluid/Blood 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).

• Brand Name: NEEDLE BLUNTLESS CANNULA / CANNULA BLUNT TIP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): NEXUS MEDICAL, LLC
• MDR Report Key: 12460536
• MDR Text Key: 271462843
• Report Number: MW5103861
• Device Sequence Number: 1
• Product Code: FPA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 09/08/2021

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 Operator: Health Professional
• Device Model Number: N0657
• Device Lot Number: 21089
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Weight: 71