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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. VAS-CATH TRANSDUCER, ULTRASONIC, DIAGNOSTIC

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BARD ACCESS SYSTEMS, INC. VAS-CATH TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Lot Number 1065
Device Problem Difficult or Delayed Positioning (1157)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/25/2020
Event Type  malfunction  
Event Description
Patient admitted for rij (right internal jugular) portacath insertion for chemotherapy administration. During the procedure, the team was unable to securely attach port to catheter during placement of portacath. Two devices were used with different lot numbers. On the third attempt, a 8-french single lumen power port catheter was placed via the right internal jugular vein. No harm to patient. Device sequestered and given to radiology manager.
 
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Brand NameVAS-CATH
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
605 north 5600 west
salt lake city UT 84116
MDR Report Key10966860
MDR Text Key220168777
Report Number10966860
Device Sequence Number1
Product Code ITX
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 11/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number1065
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/30/2020
Event Location Hospital
Date Report to Manufacturer12/08/2020
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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