MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SITE~RITE 8 ULTRASOUND SYSTEM 32MM PROBE REFURBISHED; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number	9770601Y
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
Per biomed - very dark images.

• Brand Name: SITE~RITE 8 ULTRASOUND SYSTEM 32MM PROBE REFURBISHED
• 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
• MDR Report Key: 11350939
• Report Number: 3006260740-2021-00410
• Device Sequence Number: 14274430
• Product Code: IYO
• UDI-Device Identifier: 00801741138317
• UDI-Public: (01)00801741138317
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K152554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 02/01/2021

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: 9770601Y
• Device Catalogue Number: 9770601Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other