MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE~RITE ULTRASOUND SYSTEM NEEDLE GUIDE KIT (21G) (POLYETHYLENE) (48IN); TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number N/A

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 02/11/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redr0555 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (redr0555) have been reported from the same facility in (b)(6).

Event Description

It was reported that during passage of picc, while delivering the ultrasound device's probe, the physician noticed that the cover was perforated.It was stated this occurred with two devices.This report addresses the second device.

• Brand Name: SITE~RITE ULTRASOUND SYSTEM NEEDLE GUIDE KIT (21G) (POLYETHYLENE) (48IN)
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10491044
• MDR Text Key: 206150690
• Report Number: 3006260740-2020-03130
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00801741037771
• UDI-Public: (01)00801741037771
• Combination Product (y/n): N
• PMA/PMN Number: K042445
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial
• Report Date: 09/03/2020

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
• Device Model Number: N/A
• Device Catalogue Number: 900013B01
• Device Lot Number: REDR0555
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 09/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1