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

Catalog Number	9770703
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
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 device was returned to the service facility for evaluation.During evaluation, evaluation, the reported issue of probe element failure was confirmed.The prevue ii traditional probe fails the transducer element test with 1 failed element on the right side of the probe.The probe displays a dark spot on the right side of the ultrasound image.The root cause was identified as an internal failure within the probe.
Event or Problem Description
It was reported the probe is failing the assessment test.1/16/2026 - during evaluation of the returned device, it was found the probe displays a dark spot on the right side of the ultrasound image.
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.This supplemental mdr is being submitted as a part of a remediation effort based on error occurred in the submission of mdrs for incorrect product code.

• Brand Name: BD PREVUE
• 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 UT 84116
• Manufacturer Contact: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 24121719
• Report Number: 3006260740-2026-00086
• Device Sequence Number: 9690030
• Product Code: IYO
• UDI-Device Identifier: 00801741214950
• UDI-Public: (01)00801741214950(11)230518
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K211193
• 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): 03/03/2026

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 Catalogue Number: 9770703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2023
• 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