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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN JOEY 500ML PUMP SET; PUMP, INFUSION, ENTERAL
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COVIDIEN JOEY 500ML PUMP SET; PUMP, INFUSION, ENTERAL Back to Search Results
Model Number 762055
Medical Device Problem Codes Fluid/Blood Leak (1250); Infusion or Flow Problem (2964)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/12/2020
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 there were big bubbles caused by the feed bags.Additional information received from the customer on (b)(6) 2020 stated that it looks like the sets are leaking at the valve of the pump set since that appears to be where the bubbles are originating and they are seeing wetness around the valve stem sometimes.
 
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Brand Name
JOEY 500ML PUMP SET
Common Device Name
PUMP, INFUSION, ENTERAL
Manufacturer (Section D)
COVIDIEN
15 hampshire street
mansfield MA 02048
MDR Report Key10904407
Report Number1282497-2020-09663
Device Sequence Number1462740
Product Code LZH
UDI-Device Identifier10884521072299
UDI-Public10884521072299
Combination Product (Y/N)N
Initial Reporter CountryCA
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,consum
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/25/2020
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 Number762055
Device Catalogue Number762055
Device Lot Number202510086
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/12/2020
Initial Report FDA Received Date11/25/2020
Patient Sequence Number1
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