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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC CADD ADMINISTRATION SET- FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC CADD ADMINISTRATION SET- FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7394-24
Device Problems Insufficient Flow or Under Infusion (2182); Pressure Problem (3012)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
Information was received indicating that the cadd administration set was impossible to flush despite performing a manual flush.It was also reported that the device displayed an occlusion alarm and that the liquid could not flow.There was no reported injury or adverse events.
 
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Brand Name
CADD ADMINISTRATION SET- FLOW STOP
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC
6000 nathan lane north
minneapolis, mn
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC
6000 nathan lane north
minneapolis, mn
Manufacturer Contact
dave halverson
6000 nathan lane north
minneaplois, mn 
3833310
MDR Report Key9913279
MDR Text Key186106377
Report Number3012307300-2020-02433
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586027536
UDI-Public10610586027536
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Type of Report Initial
Report Date 04/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number21-7394-24
Device Catalogue Number21-7394-24
Was Device Available for Evaluation? No
Date Manufacturer Received03/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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