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
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 device was returned to the service facility for evaluation.During evaluation, other observation found dark vertical lines in the ultrasound image and was confirmed.The 32mm probe was visually inspected upon receipt and was found to be in good physical condition but does not function properly.The root cause of the observed failure was due to an internal failure within the probe.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
Event or Problem Description
Observation found during evaluation: there are dark vertical lines in the ultrasound image due to an internal failure within the probe.

• 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: 11900632
• Report Number: 3006260740-2021-02079
• Device Sequence Number: 16494612
• Product Code: IYO
• UDI-Device Identifier: 00801741138317
• UDI-Public: (01)00801741138317
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K152554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 05/28/2021
• 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