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

Catalog Number 9770800

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2024

Event Type  malfunction  

Event Description

It was reported that there is a lot of noise at the bottom of the ultrasound image, wiggly screen/lines.Tried probe assessment, moving the probe, moving the ultrasound, no improvement.No other information provided at this time.

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.Product was not returned for evaluation/repair.Video sample provided shows noise in the ultrasound image that was received.However, complaint investigation and root cause determination could not be completed without physical evaluation of the unit.

• Brand Name: BD SITERITE 9 ULTRASOUND SYSTEM
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• 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: shelly gilbert ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18856900
• MDR Text Key: 337331040
• Report Number: 3006260740-2024-00955
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741226243
• UDI-Public: (01)00801741226243
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K231283
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9770800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other