MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SITE-RITE PREVUE PLUS; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number	9770086
Medical Device Problem Codes	Poor Quality Image (1408); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.A history review of serial number: (b)(4) showed no other similar product complaint(s) from this serial number.
Event or Problem Description
There is a dark vertical line in 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.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: observation found during evaluation of original file: there is a dark vertical line in the ultrasound image due to an internal failure within the probe.H3 other text : evaluation findings are in section h11.
Event or Problem Description
There is a dark vertical line in the ultrasound image.

• Brand Name: SITE-RITE PREVUE PLUS
• Common Device Name: 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): DYMAX CORP. -2523003; 110 marshall drive; warrendale PA 15086
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15587906
• Report Number: 3006260740-2022-03988
• Device Sequence Number: 2749477
• Product Code: IYO
• UDI-Device Identifier: 00801741095450
• UDI-Public: (01)00801741095450
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K120882
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2022

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 Model Number: 9770086
• Device Catalogue Number: 9770086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2022
• Supplement Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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