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

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.

• Brand Name: VAS-CATH
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 10966860
• MDR Text Key: 220168777
• Report Number: 10966860
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 1065
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/30/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1