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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 8884773006
Medical Device Problem Code Leak/Splash (1354)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 11/25/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Submit date: 12/07/2017.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
The customer states that after using for a few minutes, the tube started to leak.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Additional Manufacturer Narrative
This report was filed in error as this product 8884773006 is not distributed in the united states; therefore, would not meet the mdr reporting requirements in the united states.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
KANGAROO
Common Device Name
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Manufacturer (Section D)
COVIDIEN
37 insurgentes blvd
tijuana 22225
MX  22225
MDR Report Key7096302
Report Number1282497-2017-05524
Device Sequence Number1378679
Product Code LZH
UDI-Device Identifier20884521028385
UDI-Public20884521028385
Combination Product (Y/N)N
Initial Reporter CountryTW
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date (Section B) 04/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date01/30/2022
Device Model Number8884773006
Device Catalogue Number8884773006
Device Lot Number161900181
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/29/2017
Supplement Date Received by Manufacturer11/29/2017
11/29/2017
Initial Report FDA Received Date12/07/2017
Supplement Report FDA Received Date04/04/2018
04/05/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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