MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE~RITE 8 ULTRASOUND SYSTEM W/PINPOINT GT; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 9770501

Device Problem Signal Artifact/Noise (1036)

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

Event Description

Sales rep reported on behalf of hospital that the image on site rite 8 ultrasound system with pinpoint gt (9770501) is "snowy" and looks to have some artifact that looks like rain.The artifact is there all the time, even while scanning on patients.Image attached.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the device was returned to the service facility for evaluation.During evaluation, the reported issue of poor image quality is confirmed.The probe has a damaged strain relief & interference on the ultrasound image.The root cause of the reported issue is a failure of the probe strain relief.No other functionality issues with the equipment were found during evaluation/servicing.The device was serviced, tested and returned to the customer.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.

Event Description

Sales rep reported on behalf of hospital that the image on site rite 8 ultrasound system with pinpoint gt (9770501) is "snowy" and looks to have some artifact that looks like rain.The artifact is there all the time, even while scanning on patients.

• Brand Name: SITE~RITE 8 ULTRASOUND SYSTEM W/PINPOINT GT
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7834067
• MDR Text Key: 118886510
• Report Number: 3006260740-2018-02289
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741098338
• UDI-Public: (01)00801741098338
• Combination Product (y/n): N
• PMA/PMN Number: K152554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/03/2019

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: 9770501
• Device Catalogue Number: 9770501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2018
• Supplement Dates Manufacturer Received: 06/12/2019
• Supplement Dates FDA Received: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1