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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN KANGAROO JOEY,PUMP W/CLMP,REFB; PUMP, INFUSION, ENTERAL
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COVIDIEN KANGAROO JOEY,PUMP W/CLMP,REFB; PUMP, INFUSION, ENTERAL Back to Search Results
Model Number 383401
Medical Device Problem Code Infusion or Flow Problem (2964)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/01/2021
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.
 
Event or Problem Description
The customer reported that the device provided inaccurate volume infusion.There was no patient harm reported.
 
Additional Manufacturer Narrative
Upon further review of all available information, it was determined that this event was inadvertently reported in error as the details of the incident do not meet the criteria of a reportable malfunction or event.No further follow up reports will be submitted.
 
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Brand Name
KANGAROO JOEY,PUMP W/CLMP,REFB
Common Device Name
PUMP, INFUSION, ENTERAL
Manufacturer (Section D)
COVIDIEN
15 hampshire street
mansfield MA 02048
MDR Report Key12452816
Report Number1282497-2021-10599
Device Sequence Number14469857
Product Code LZH
UDI-Device Identifier10884521144019
UDI-Public10884521144019
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 10/14/2021
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 No Information
Device Model Number383401
Device Catalogue Number383401
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 09/01/2021
Supplement Date Received by Manufacturer09/01/2021
Initial Report FDA Received Date09/10/2021
Supplement Report FDA Received Date10/14/2021
Patient Sequence Number1
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