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U.S. Department of Health and Human Services

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

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COVIDIEN / CARDINAL HEALTH 200, LLC COVIDIEN MONOJECT SYRINGE; SALINE, VASCULAR ACCESS FLUSH Back to Search Results
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).
 
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Brand Name
COVIDIEN MONOJECT SYRINGE
Type of Device
SALINE, VASCULAR ACCESS FLUSH
Manufacturer (Section D)
COVIDIEN / CARDINAL HEALTH 200, LLC
MDR Report Key12008116
MDR Text Key256792419
Report NumberMW5101906
Device Sequence Number1
Product Code NGT
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 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 Received06/15/2021
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age3 YR
Patient Weight6
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