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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH JOEY 1000ML PUMP SET; PUMP, INFUSION, ENTERAL

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CARDINAL HEALTH JOEY 1000ML PUMP SET; PUMP, INFUSION, ENTERAL Back to Search Results
Model Number 763656
Device Problem Air/Gas in Device (4062)
Patient Problem Discomfort (2330)
Event Date 03/23/2022
Event Type  malfunction  
Event Description
Customer reports: tiny air bubbles appeared in the feeding tube section between the pump and the patient.The patient was experiencing discomfort for the last week and mother just noticed the air bubbles in the tubing today.The patient is unable to communicate verbally.
 
Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
 
Manufacturer Narrative
The device was not received for evaluation however photographs were provided and analyzed confirming the reported condition.  a corrective and preventive action has been initiated to address the reported issue.
 
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Brand Name
JOEY 1000ML PUMP SET
Type of Device
PUMP, INFUSION, ENTERAL
Manufacturer (Section D)
CARDINAL HEALTH
777 west street
mansfield MA 02048
Manufacturer (Section G)
CARDINAL HEALTH
777 west street
mansfield MA 02048
Manufacturer Contact
jill saraiva
777 west street
mansfield, MA 02048
5086183640
MDR Report Key13893162
MDR Text Key288047028
Report Number1282497-2022-10683
Device Sequence Number1
Product Code LZH
UDI-Device Identifier10884521072305
UDI-Public10884521072305
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/26/2022
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
Device Model Number763656
Device Catalogue Number763656
Device Lot Number210810122
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/23/2022
Initial Date FDA Received03/24/2022
Supplement Dates Manufacturer Received03/23/2022
Supplement Dates FDA Received05/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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