MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BD SITERITE 9 ULTRASOUND SYSTEM; GENERAL-PURPOSE ULTRASOUND IMAGING SYSTEM

Model Number	N/A
Medical Device Problem Codes	Poor Quality Image (1408); Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported probe image distorted, greyed out.Poor image quality.Failing probe assessment test at times.No further information was provided.
Additional 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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.

• Brand Name: BD SITERITE 9 ULTRASOUND SYSTEM
• Common Device Name: GENERAL-PURPOSE ULTRASOUND IMAGING SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer Contact: becky sparks ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 25875630
• Report Number: 3006260740-2026-05112
• Device Sequence Number: 20842337
• Product Code: IYO
• UDI-Device Identifier: 00801741226274
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K231283
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 9770803
• Device Lot Number: N/A
• Date Returned to Manufacturer: 07/14/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2026
• Supplement Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 07/20/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown