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 Defective Component (2292)

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

Event Date 01/26/2024

Event Type  malfunction  

Event Description

Found during evaluation at bd service center: the ultrasound image produced is very dark.The transducer element test shows 6 bad elements out of 8 total.The root cause is due to an internal failure of the probe.

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 site rite prevue ii cue probe was visually inspected upon receipt and was found to be in poor physical condition.The reported issue of probe doesn't work is confirmed.The ultrasound image produced is very dark.The transducer element test shows 6 bad elements out of 8 total.The root cause 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: 18754574
• MDR Text Key: 335966849
• Report Number: 3006260740-2024-00689
• Device Sequence Number: 1
• Product Code: IYO
• 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: 02/01/2024

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: 9770703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2024
• Initial Date FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2021
• 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