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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH KANGAROO JOEYPUMP W/POLE CLMP; PUMP, INFUSION, ENTERAL

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CARDINAL HEALTH KANGAROO JOEYPUMP W/POLE CLMP; PUMP, INFUSION, ENTERAL Back to Search Results
Model Number 383400
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problem Insufficient Information (4580)
Event Date 09/07/2021
Event Type  malfunction  
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 Description
The customer reported that the device's flow was not conforming.Additional information was provided stating that the issue happened during reconditioning test.The device flowed faster than the set rate.
 
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Brand Name
KANGAROO JOEYPUMP W/POLE CLMP
Type of Device
PUMP, INFUSION, ENTERAL
Manufacturer (Section D)
CARDINAL HEALTH
15 hampshire street
mansfield MA 02048
Manufacturer (Section G)
CARDINAL HEALTH
15 hampshire street
mansfield MA 02048
Manufacturer Contact
jill saraiva
15 hampshire street
mansfield, MA 02048
5086183640
MDR Report Key12453740
MDR Text Key272124674
Report Number1282497-2021-10601
Device Sequence Number1
Product Code LZH
UDI-Device Identifier10884521006645
UDI-Public10884521006645
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 09/10/2021
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
Device Operator No Information
Device Model Number383400
Device Catalogue Number383400
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 09/08/2021
Initial Date FDA Received09/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
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