MAUDE Adverse Event Report: COVIDIEN / CARDINAL HEALTH 200, LLC COVIDIEN MONOJECT SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Device Problems Crack (1135); Leak/Splash (1354); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 05/11/2021

Event Type  No Answer Provided  

Event Description

On (b)(6) 2021 12:58 am by not authenticated - rn (b)(6) cefoxitin to run over 15 minutes.When hanging normal saline flush, noticed puddle on floor.Rn pushed a small amount of ns through and noticed saline leaking from top of medication tubing.Inspected medication tubing and noticed crack at top of tubing that connects to syringe.Notified ccl.Syringe medication tubing replaced.Defective syringe tubing kept.Fda safety report id# (b)(4).

• Brand Name: COVIDIEN MONOJECT SYRINGE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): COVIDIEN / CARDINAL HEALTH 200, LLC
• MDR Report Key: 12008116
• MDR Text Key: 256792419
• Report Number: MW5101906
• Device Sequence Number: 1
• Product Code: NGT
• 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: 06/11/2021

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/15/2021
• 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: 3 YR
• Patient Weight: 6