• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN COVIDIEN MONOJECT FLUSH SYRINGE, 10 ML FILL SYRINGE, PISTON

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COVIDIEN COVIDIEN MONOJECT FLUSH SYRINGE, 10 ML FILL SYRINGE, PISTON Back to Search Results
Device Problems Gas Leak (2946); Pressure Problem (3012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/23/2020
Event Type  malfunction  
Event Description
A 10 cc prefilled flushes noted to have negative pressure which draws the fluid back into the syringe. The issue was originally noted while the rn was preparing for initiation of iv. She flushed the extension tubing (aka j loop) only to find that the fluid she previously placed into the j loop withdrew into the syringe. Therefore, the j loop was not filled with saline as expected, but air. Depending on pt size, an inadvertent bolus of air could cause harm. This issue was reproduced across various attempts with a variety of lot numbers.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCOVIDIEN MONOJECT FLUSH SYRINGE, 10 ML FILL
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
COVIDIEN
MDR Report Key9665562
MDR Text Key177883991
Report NumberMW5092727
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
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 01/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

-
-