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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. FAST-CATH INTRODUCER, CATHETER

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ST. JUDE MEDICAL, INC. FAST-CATH INTRODUCER, CATHETER Back to Search Results
Model Number 406137
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 01/30/2021
Event Type  malfunction  
Event Description
Upon assessing the patient, noted bleeding from introducer site. At a closer look it was discovered sideport was dislodged.
 
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Brand NameFAST-CATH
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
14901 deveau pl.
minnetonka MN 55345
MDR Report Key11300645
MDR Text Key230960333
Report Number11300645
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/02/2021,02/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number406137
Device Catalogue Number406137
Device Lot Number7462611
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/02/2021
Event Location Hospital
Date Report to Manufacturer02/09/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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