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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN KANGAROO; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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COVIDIEN KANGAROO; TUBES, GASTROINTESTINAL (AND ACCESSORIES) Back to Search Results
Model Number UNKNOWN
Device Problem Leak/Splash (1354)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
 
Event Description
The customer reported that an unknown enteral feeding set leaked from an unknown location.No additional information is available.
 
Manufacturer Narrative
The reported issue of 'leaking' could not be confirmed at this time.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.Complaint trending information is reviewed on a routine basis and if a trend is observed, actions will be taken as necessary.
 
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Brand Name
KANGAROO
Type of Device
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Manufacturer (Section D)
COVIDIEN
15 hampshire st
mansfieldm MA 02048
MDR Report Key8344596
MDR Text Key136305367
Report Number1282497-2019-08274
Device Sequence Number1
Product Code KNT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 03/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received01/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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