MAUDE Adverse Event Report: COVIDIEN COVIDIEN MONOJECT; CANNULA SURGICAL, GENERAL & PLASTIC SURGERY

Lot Number 912300

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/20/2019

Event Type  malfunction  

Event Description

Nurse was drawing up medication into the 3 ml monoject vial access cannula.The medication began squirting out other side of the plastic needle.There was a small hole on the side of the plastic needle where the medication was squirting out of.Fda safety report id # (b)(4).

• Brand Name: COVIDIEN MONOJECT
• Type of Device: CANNULA SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN ; mansfield MA
• MDR Report Key: 8930808
• MDR Text Key: 155652433
• Report Number: MW5089290
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Lot Number: 912300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 1 DA