MAUDE Adverse Event Report: SITE-RITE 8 ULTRASOUND SYSTEM 20MM PINPOINT GT PROBE (REMANUFACTURED); SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number	N/A
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	08/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
Event or Problem Description
During evaluation of the returned device, it was found that the probe has red marks on the calibration point and produces rain like 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 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 found during evaluation at bd service facility: the probe has red marks on the calibration point and produces rain like image.The root cause of the failure was identified as an internal probe failure was confirmed.
Event or Problem Description
During evaluation of the returned device, it was found that the probe has red marks on the calibration point and produces rain like image.

• Brand Name: SITE-RITE 8 ULTRASOUND SYSTEM 20MM PINPOINT GT PROBE (REMANUFACTURED)
• Common Device Name: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• MDR Report Key: 12443219
• Report Number: 3006260740-2021-03716
• Device Sequence Number: 17057634
• Product Code: IYO
• UDI-Device Identifier: 00801741138201
• UDI-Public: (01)00801741138201
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 09/13/2021

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: N/A
• Device Catalogue Number: 9770602Y
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 09/15/2021
• 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