MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE RITE 8 ULTRASOUND SYSTEM 20MM CUE LINEAR PROBE; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 9770603

Device Problem Poor Quality Image (1408)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and is pending evaluation.Results are expected soon.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.

Event Description

Per rn, picture issues as of late.Used a different probe and noticed a significant difference in the picture quality.

Event Description

Per rn, picture issues as of late.Used a different probe and noticed a significant difference in the picture quality.

Manufacturer Narrative

H11:section a through f - 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 picture issues as of late with their sr8.Used a different cue probe and noticed a significant difference in the picture quality was unconfirmed; the image quality meets manufacturer specifications.A test probe was used to compare the quality of the image on the probe.The root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.A history review of serial number (b)(6) showed no other similar product complaint(s) from this serial number.

• Brand Name: SITE RITE 8 ULTRASOUND SYSTEM 20MM CUE 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: 10490410
• MDR Text Key: 205704447
• Report Number: 3006260740-2020-03114
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00801741138218
• UDI-Public: (01)00801741138218
• Combination Product (y/n): N
• PMA/PMN Number: K182281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/06/2020

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: 9770603
• Device Catalogue Number: 9770603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/14/2020
• Initial Date FDA Received: 09/03/2020
• Supplement Dates Manufacturer Received: 10/26/2020
• Supplement Dates FDA Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1