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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX UMBILICAL ARTERY TRANSDUCING TUBING

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SMITHS MEDICAL ASD, INC. MEDEX UMBILICAL ARTERY TRANSDUCING TUBING Back to Search Results
Model Number MX9644
Device Problem Leak/Splash (1354)
Patient Problem No Information (3190)
Event Date 05/03/2018
Event Type  malfunction  
Event Description
"umbilical artery transducing tubing was dripping fluid out of the clamp with the orange dot. We tried to prime the tubing twice. ".
 
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Brand NameMEDEX
Type of DeviceUMBILICAL ARTERY TRANSDUCING TUBING
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key7620067
MDR Text Key111735789
Report Number7620067
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 05/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMX9644
Device Catalogue NumberMX9644
Device Lot Number3515521
Other Device ID NumberKIT 31
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/22/2018
Event Location Hospital
Date Report to Manufacturer05/22/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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