MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 REFURB, SITE-RITE 8; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number	9770501R
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.A history review of serial number (b)(4) showed one similar complaint from this serial number.The similar complaint has been reported by the same us facility.The previous complaint evaluation for this serial number ((b)(4)) are: confirmed, root cause was identified as display or visual feedback problem.(reference: mdr number 3006260740-2020-00827).
Event or Problem Description
Per biomed - screen has a rain effect and also has a green ring on the screen.
Event or Problem Description
Per biomed - screen has a rain effect and also has a green ring on the screen.
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 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 information, the following was concluded: the device was returned to the service facility for evaluation.During evaluation, the reported issue of poor image quality was confirmed.The scanner image is displaying rain like image.The root cause of the reported issue is a probe failure.A history review of serial number (b)(6) showed one similar complaint from this serial number.The similar complaint has been reported by the same us facility.The previous complaint evaluation for this serial number (b)(6) are: 1.Confirmed, root cause was identified as display or visual feedback problem.(reference: mdr number 3006260740-2020-00827) h3 other text : evaluation findings are in section h.11.

• Brand Name: REFURB, SITE-RITE 8
• 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: 11609583
• Report Number: 3006260740-2021-01118
• Device Sequence Number: 3866181
• Product Code: IYO
• UDI-Device Identifier: 00801741104138
• UDI-Public: (01)00801741104138
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 05/18/2021

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: 9770501R
• Device Catalogue Number: 9770501R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 05/20/2021
• 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