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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH, INC. KANGAROO; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
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CARDINAL HEALTH, INC. KANGAROO; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS Back to Search Results
Model Number 461055E
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 06/30/2021
Event Type  malfunction  
Event Description
One of the feeding ports on the patient's duotube, from the kangaroo feeding tube with iris technology, broke off so the tube had to be removed and replaced.This is a recurrent problem with these tubes according to the registered nurse who insert them into patients.The original package is not available.
 
Event Description
One of the feeding ports on the patient's duotube, from the kangaroo feeding tube with iris technology, broke off so the tube had to be removed and replaced.This is a recurrent problem with these tubes according to the registered nurse who insert them into patients.The original package is not available.
 
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Brand Name
KANGAROO
Type of Device
GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
Manufacturer (Section D)
CARDINAL HEALTH, INC.
15 hampshire street
mansfield MA 02048
MDR Report Key12180153
MDR Text Key261937572
Report Number12180153
Device Sequence Number1
Product Code PIF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 07/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number461055E
Device Catalogue Number461055E
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/07/2021
Date Report to Manufacturer07/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age29930 DA
Patient SexFemale
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