MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. SITERITE; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Patient Problem Insufficient Information (4580)

Event Date 01/30/2023

Event Type  malfunction  

Event Description

Vascular access team nurse was inserting a picc line at bedside when the bard site rite unexpected turned off during the procedure despite being plugged into the wall outlet.Biomed troubleshot the machine and was able to get it to turn back on.The patient had to go to ir for double lumen picc placement for tpn.

• Brand Name: SITERITE
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 18215865
• MDR Text Key: 329114594
• Report Number: 18215865
• Device Sequence Number: 1
• Product Code: IYO
• 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: 10/27/2023,09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/27/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/28/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18615 DA
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Race: Black Or African American