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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN KANGAROO; PUMP, INFUSION, ENTERAL
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COVIDIEN KANGAROO; PUMP, INFUSION, ENTERAL Back to Search Results
Model Number 775100
Device Problems Defective Component (2292); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/07/2018
Event Type  malfunction  
Event Description
Kangaroo safety screw spike with flush bag tubing: defective.(b)(4).The screw in spike should turn in order to spike the tube feeding bottle and screw to secure.The collar around the spike should turn.There have been occurrences of the tubing that the collars are fixed to the spike therefore unable to secure to the tubing to the bottle of tube feeding.
 
Event Description
Kangaroo safety screw spike with flush bag tubing -defective.Ref# (b)(4).The screw in spike should turn in order to spike the tube feeding bottle and screw to secure.The collar around the spike should turn.There have been occurrences of the tubing that the collars are fixed to the spike therefore unable to secure to the tubing to the bottle of tube feeding.
 
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Brand Name
KANGAROO
Type of Device
PUMP, INFUSION, ENTERAL
Manufacturer (Section D)
COVIDIEN
15 hampshire st.
mansfield MA 02048
MDR Report Key7501889
MDR Text Key107851752
Report Number7501889
Device Sequence Number1
Product Code LZH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup
Report Date 05/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2021
Device Model Number775100
Device Catalogue Number775100
Device Lot Number180590061
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/07/2018
Event Location Hospital
Date Report to Manufacturer05/10/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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