MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. SITE-RITE 8 ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 9770600

Device Problems Computer Software Problem (1112); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/13/2022

Event Type  malfunction  

Event Description

Went to hospital for picc (peripherally inserted central catheter) line insertion in evening.Discovered ultrasound does not currently have the tip location device on enabled on ultrasound.Called after hours biomed was not able to add tip location.We tried hard to get it working but was not able to.I was there for a couple hours.I was not able to proceed with insertion.Left message today for biomed 2 days later.This is an outside vendor for the picc.

• Brand Name: SITE-RITE 8 ULTRASOUND SYSTEM
• 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: 15515812
• MDR Text Key: 300903466
• Report Number: 15515812
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/16/2022,08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9770600
• Device Catalogue Number: 9770600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/16/2022
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 13870 DA
• Patient Sex: Male