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

Model Number N/A

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

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

Event Date 10/31/2023

Event Type  malfunction  

Event Description

It was reported very poor image quality.

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 has not been received by the manufacturer for evaluation.

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 following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the site rite prevue ii was visually inspected upon receipt and was found to be in good physical condition.The reported issue of poor image quality is unconfirmed.The ultrasound image produced is bright and clear and of similar quality to acceptable examples.There is no root cause due to the reported issue being unconfirmed.

Event Description

It was reported very poor image quality.

• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18092221
• MDR Text Key: 327627964
• Report Number: 3006260740-2023-05063
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

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 Model Number: N/A
• Device Catalogue Number: 9770700
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/08/2023
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 12/13/2023
• 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