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

Model Number	N/A
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Per tm: unit has poor image quality.
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 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 no other similar product complaint(s) from this serial number.
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 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 no other similar product complaint(s) from this serial number.
Event or Problem Description
Per tm: unit has poor image quality.
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 this information, the following was concluded: the device was returned to the service facility for evaluation.During evaluation, the reported issue of unit has poor image quality was confirmed.The reported issue is confirmed.The unit displays a poor image quality.Reported issue root cause: the root cause is due to an internal failure within the gt probe.
Event or Problem Description
Per tm - unit has poor image quality.

• 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
• Manufacturer (Section G): DYMAX CORP. -2523003; 110 marshall drive; warrendale PA 15086
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13425464
• Report Number: 3006260740-2022-00140
• Device Sequence Number: 4034239
• Product Code: IYO
• UDI-Device Identifier: 00801741104138
• UDI-Public: (01)00801741104138
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2022

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: N/A
• Device Catalogue Number: 9770501R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/14/2022
• Supplement Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 02/11/2022
• 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