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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 8884752042E
Medical Device Problem Code Leak/Splash (1354)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 09/23/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, the y-connector connection is cracked causing leakage.There is no reported patient involvement.No additional information is available.
 
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Brand Name
KANGAROO
Common Device Name
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Manufacturer (Section D)
COVIDIEN
calle 9 sur no. 1113 cuidad
tijuana,na 22444
MX  22444
MDR Report Key7974444
Report Number9612030-2018-00149
Device Sequence Number16447705
Product Code KNT
UDI-Device Identifier30884521664061
UDI-Public30884521664061
Combination Product (Y/N)N
Initial Reporter CountryFR
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
Report Date (Section B) 10/17/2018
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 Date03/01/2023
Device Model Number8884752042E
Device Catalogue Number8884752042E
Device Lot Number1805791664
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/12/2018
Initial Report FDA Received Date10/17/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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