MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BD PREVUE II PERIPHERAL VASCULAR ACCESS SYSTEM 20MM TRADITIONAL PROBE; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Catalog Number 9770703

Device Problem Poor Quality Image (1408)

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

Event Date 02/10/2024

Event Type  malfunction  

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 service facility for evaluation.During evaluation, the reported issue of probe has a dark area on the image was confirmed.The probe has 2 failed transducer elements which cause a dark spot in the ultrasound image.The root cause is due to an internal failure of the probe.H3 other text : evaluation summary findings in h:11.

Event Description

Observation found during evaluation at bd service center: the probe has 2 failed transducer elements which cause a dark spot in the ultrasound image.This issue is due to an internal failure of the probe.

• Brand Name: BD PREVUE II PERIPHERAL VASCULAR ACCESS SYSTEM 20MM TRADITIONAL PROBE
• 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: 18841535
• MDR Text Key: 336968327
• Report Number: 3006260740-2024-00921
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741214950
• UDI-Public: (01)00801741214950
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211193
• 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: 02/12/2024

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 Catalogue Number: 9770703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2024
• Initial Date FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2021
• 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