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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. CADD; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7349-24
Device Problems Complete Blockage (1094); Obstruction of Flow (2423)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
Information was received indicating that a smiths medical tubing did not allow fluid to flow.The pump works fine but no fluid drains from the bag.There were no reported adverse events.The issue was resolved by changing the tubing.
 
Manufacturer Narrative
Device evaluation- two device samples were returned for evaluation.Visual inspection of the devices showed no abnormalities.The devices were connected to cadd-legacy infusion pumps and given functional testing.The devices were found to allow for priming but some resistance occurred at the free flow flow stop device.Examination at this area showed the devices were returned to smiths medical without the blue clips and kinking at this area of the tube was the cause of the resistance.The blue clips are required to remain on the tubing until connected with pump.The devices could not be further tested due to their returned condition.
 
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Brand Name
CADD
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key11112439
MDR Text Key225038919
Report Number3012307300-2021-00038
Device Sequence Number1
Product Code FPA
UDI-Device Identifier15019517184235
UDI-Public15019517184235
Combination Product (y/n)N
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 03/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number21-7349-24
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2021
Was the Report Sent to FDA? No
Date Manufacturer Received12/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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