MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. SITE RITE; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number 90013B01

Device Problem Unexpected Color (4055)

Patient Problem Insufficient Information (4580)

Event Date 01/13/2022

Event Type  malfunction  

Event Description

During picc placement, noticed that site rite needle guides were colored incorrectly.The 1.0 guide was dark green and should have been light green.Could not gain access into vein.Unsure if guide was just the wrong color of if the angle was that of the 1.5 guide instead of the 1.0.Site rite needle guide kit lot #refw4302.

• Brand Name: SITE RITE
• 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: 13479651
• MDR Text Key: 285231831
• Report Number: 13479651
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/01/2022

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 Model Number: 90013B01
• Device Catalogue Number: REFW4302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/01/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/08/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other