MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE~RITE 5 ULTRASOUND SYSTEM CLASS II SCANNER; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Catalog Number 9763000

Device Problem Poor Quality Image (1408)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Poor display clarity, puzzling the insertion visualization.

• Brand Name: SITE~RITE 5 ULTRASOUND SYSTEM CLASS II SCANNER
• 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.; 141 zehner school road; zelienople PA 16063
• Manufacturer Contact: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 8947148
• MDR Text Key: 156398982
• Report Number: 3006260740-2019-02536
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00801741091032
• UDI-Public: (01)00801741091032
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K052517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9763000
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 08/05/2019
• 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?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1