MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE-RITE PREVUE PLUS; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number N/A

Device Problems Crack (1135); Poor Quality Image (1408)

Patient Problem Discomfort (2330)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned, at this time, to the manufacturer for evaluation.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.Device has not yet been returned for evaluation.

Event Description

As reported by the facility via capital equipment facility was using a prevue+ (sn (b)(4)) which reportedly had chipping/cracking around the probe where you scan the patient.This caused the patient discomfort and image quality issues.No patient injury was reported.

• Brand Name: SITE-RITE PREVUE PLUS
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): DYMAX CORP. -2523003; 110 marshall drive; warrendale PA 15086
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 7308510
• MDR Text Key: 101512435
• Report Number: 3006260740-2018-00327
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741095450
• UDI-Public: (01)00801741095450
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120882
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• 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: 9770086
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1