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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MONOJECT; SYRINGE, PISTON
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COVIDIEN MONOJECT; SYRINGE, PISTON Back to Search Results
Catalog Number 118600077
Device Problems Sticking (1597); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/11/2018
Event Type  malfunction  
Event Description
Syringe modules for the alaris iv pumps alarming repeatedly, occlusion on patient side.The pumps were infusing at a rate of 1.5 mls/hr and using 60 ml monoject syringes (cardinal).Staff indicated it was almost impossible to get the syringes to infuse for more than just a few minutes at a time even with switching out the syringe, before another alarm was triggered.There was nothing wrong on the patient side.It appeared liked the syringes were stuck and could not push the plunger without force.This has continued to occur.This continued to happen with several monoject syringes throughout the shift.
 
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Brand Name
MONOJECT
Type of Device
SYRINGE, PISTON
Manufacturer (Section D)
COVIDIEN
815 tek dr.
crystal lake IL 60014
MDR Report Key7243920
MDR Text Key99110360
Report Number7243920
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 User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 01/18/2018,01/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2018
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Catalogue Number118600077
Device Lot Number721415X
Other Device ID Number60 ML
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/18/2018
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer01/18/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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