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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGYLE CATHETER, UMBILICAL ARTERY

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ARGYLE CATHETER, UMBILICAL ARTERY Back to Search Results
Model Number 8888160333
Device Problem Break (1069)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 08/01/2021
Event Type  malfunction  
Event Description
During its removal, the argyle¿ umbilical vessel catheter broke 1. 5cm above the insertion site. The catheter line was held in place until provider arrived. The entire remaining length was removed with a hemostat. Blood loss was minimal.
 
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Brand NameARGYLE
Type of DeviceCATHETER, UMBILICAL ARTERY
MDR Report Key12404956
MDR Text Key269396002
Report Number12404956
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 08/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888160333
Device Catalogue Number8888160333
Device Lot Number2007100042
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/23/2021
Event Location No Information
Date Report to Manufacturer09/01/2021
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? No
Type of Device Usage Unkown

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