MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE~RITE 8 ULTRASOUND SYSTEM 32 MM LINEAR PROBE; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 9770600

Device Problem Display or Visual Feedback Problem (1184)

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

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) review is not possible, as the device is manufactured using a unique serial number and not by lot number.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.

Event Description

It was reported that the probe shows crystals and a line on the screen, preventing the image from being read.

Manufacturer Narrative

The information provided by bd 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 bd.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 probe shows crystals and a line on the screen, preventing the image from being read was confirmed.There are two dark vertical areas in the image.The root cause is an internal failure in the probe.The review of the dhr, sub-assembly dhr, sub-assembly manufacturing, component records, manufacturing process changes, mrr/mrb, and internal rejects showed that the reported issue is not likely related to a manufacturing issue.No other functionality issues with the equipment were found during evaluation/servicing.A lot history review (lhr) review is not possible, as the device is manufactured using a unique serial number and not by lot number.A history review of serial number dycqag525 showed no other similar product complaint(s) from this serial number.

Event Description

It was reported that the probe shows crystals and a line on the screen, preventing the image from being read.

• Brand Name: SITE~RITE 8 ULTRASOUND SYSTEM 32 MM LINEAR PROBE
• 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: 8190876
• MDR Text Key: 131334008
• Report Number: 3006260740-2018-03737
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741138263
• UDI-Public: (01)00801741138263
• Combination Product (y/n): N
• PMA/PMN Number: K152554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9770600
• Device Catalogue Number: 9770601
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2018
• Event Location: Hospital
• Date Manufacturer Received: 02/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1