MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE~RITE VISION DISPLAY; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Catalog Number 9770032

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Erratic or Intermittent Display (1182)

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

Event Type  malfunction  

Manufacturer Narrative

The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device has not been returned to the manufacturer for evaluation, as there was a verbal resolution.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

Per surgery nurse: vision system #(b)(4) has frozen on her twice in the last few months.Freezing issue has occurred in the middle of procedure while advancing the picc while in the sherlock mode.The 2nd time the system froze, it then displayed a black screen with an error stating it would shut down and then it shut down.System is currently running up to date software (1.0.5).A keyboard, flash drive and sherlock 3cg sensor were connected to system at time of freezing.

• Brand Name: SITE~RITE VISION DISPLAY
• Type of Device: SYSTEM, IMAGING, PULSED DOPPLER, 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: tesha udy ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225819
• MDR Report Key: 7276823
• MDR Text Key: 100529598
• Report Number: 3006260740-2018-00227
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/16/2018

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 Catalogue Number: 9770032
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2018
• 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