MAUDE Adverse Event Report: NEXUS MEDICAL, LLC NEXUS MEDICAL PLASTIC BLUNT CANNULA ( PRODUCT # N06576); SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Product Quality Problem (1506)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Use of nexus medical plastic blunt cannula (product # n06576) leads to rubber stopper being push all the way in.Occurred on multiple vials with different healthcare providers.Occurs when used with 13 mm size vials.Fda safety report id # (b)(4).

• Brand Name: NEXUS MEDICAL PLASTIC BLUNT CANNULA ( PRODUCT # N06576)
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): NEXUS MEDICAL, LLC
• MDR Report Key: 12238701
• MDR Text Key: 264077309
• Report Number: MW5102796
• Device Sequence Number: 1
• Product Code: FPA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 07/23/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/27/2021
• 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