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

Catalog Number 9770700

Device Problems Poor Quality Image (1408); No Apparent Adverse Event (3189)

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

Event Date 01/25/2024

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 manufacturer has received the sample and is pending evaluation.Results are expected soon.

Event Description

Per tm - the ultrasound system has severe lag and the image is completely distorted.System worked briefly at initial start up and then after an hour it no longer worked despite switching probes and shutting down system.No other information was provided.

Event Description

Per tm - the ultrasound system has severe lag and the image is completely distorted.System worked briefly at initial start up and then after an hour it no longer worked despite switching probes and shutting down system.No other information was provided.

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 device was returned to service facility for evaluation.During evaluation, the reported issue of the unit is taking a long time to turn on and there is poor image quality was unconfirmed.The ultrasound system is not experiencing lag and the image is not distorted.There is no root cause as the issue could not be reproduced.H3 other text : evaluation summary findings in h:11.

• Brand Name: BD PREVUE II PERIPHERAL VASCULAR ACCESS 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: 18728134
• MDR Text Key: 336642004
• Report Number: 3006260740-2024-00650
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741214912
• UDI-Public: (01)00801741214912
• 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,Followup
• Report Date: 03/01/2024

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: 9770700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/16/2024
• Supplement Dates Manufacturer Received: 03/01/2024
• Supplement Dates FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2023
• 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