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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH EPUMP SAFETY SCREW SPIKE SET; PUMP, INFUSION, ENTERAL
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CARDINAL HEALTH EPUMP SAFETY SCREW SPIKE SET; PUMP, INFUSION, ENTERAL Back to Search Results
Model Number 775659
Device Problem Fluid/Blood Leak (1250)
Patient Problem Insufficient Information (4580)
Event Date 05/24/2021
Event Type  malfunction  
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 Description
As reported through anvisa notification (b)(4) - the nutrition diet was leaking from the equipment.
 
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Brand Name
EPUMP SAFETY SCREW SPIKE SET
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 Key11979621
MDR Text Key258746654
Report Number1282497-2021-10248
Device Sequence Number1
Product Code LZH
UDI-Device Identifier10884521155831
UDI-Public10884521155831
Combination Product (y/n)N
Reporter Country CodeBR
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 06/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number775659
Device Catalogue Number775659
Device Lot Number202860058
Date Manufacturer Received06/09/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
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