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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN JOEY 1000ML PUMP SET; PUMP, INFUSION, ENTERAL
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COVIDIEN JOEY 1000ML PUMP SET; PUMP, INFUSION, ENTERAL Back to Search Results
Model Number 763656
Medical Device Problem Codes Fluid/Blood Leak (1250); Air/Gas in Device (4062)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/18/2021
Type of Reportable Event Malfunction
Additional 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 or Problem Description
The patient's mother reported that there were issues with the feeding sets tubings.The rod which is usually inserted or the round piece which is inserted into the feeding pump came off the tubing on it's own, when changing the bag it leaked every where, and there were air bubbles in the line.There were no injuries to the patient.
 
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Brand Name
JOEY 1000ML PUMP SET
Common Device Name
PUMP, INFUSION, ENTERAL
Manufacturer (Section D)
COVIDIEN
15 hampshire street
mansfield MA 02048
MDR Report Key11254862
Report Number1282497-2021-09880
Device Sequence Number3977407
Product Code LZH
UDI-Device Identifier10884521072305
UDI-Public10884521072305
Combination Product (Y/N)N
Initial Reporter CountryCA
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer,foreign
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/29/2021
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 Number763656
Device Catalogue Number763656
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/19/2021
Initial Report FDA Received Date01/29/2021
Patient Sequence Number1
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