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

Model Number 9770601

Device Problem Poor Quality Image (1408)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

Per tm - blurry image reported before any use on a patient.

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 blurry ultrasound image was unconfirmed.Using the in house test scanner the probe functioned normally without any ec 201 errors.The scanner was evaluated with the model 550 phantom and the image was found to be normal for a sr 8 scanner.The root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.No other functionality issues with the equipment were found during evaluation/servicing a history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.

Event Description

Per tm - blurry image reported before any use on a patient.

• Brand Name: SITE-RITE 8 32MM ULTRASOUND PROBE, US
• 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: 8728676
• MDR Text Key: 149074022
• Report Number: 3006260740-2019-01756
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00801741138294
• UDI-Public: (01)00801741138294
• 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
• Type of Report: Initial,Followup
• Report Date: 11/01/2019

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: 9770601
• Device Catalogue Number: 9770601
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/31/2019
• Initial Date FDA Received: 06/24/2019
• Supplement Dates Manufacturer Received: 10/07/2019
• Supplement Dates FDA Received: 11/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1