MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SITE~RITE 8 ULTRASOUND SYSTEM 20 MM PINPOINT GT; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number	9770602X
Medical Device Problem Codes	Defective Component (2292); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
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, the reported issue of poor image quality was unconfirmed.The site rite 8 was visually inspected upon receipt and was found to be in poor physical condition.The reported issue is unconfirmed; the probe¿s image has white line coming up from the bottom of the screen.There is no error when the probe is plugged in.The root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
Event or Problem Description
Found during evaluation: the probe¿s image has white lines coming up from the bottom of the screen.There is no error when the probe is plugged in.
Event or Problem Description
Found during evaluation at the service facility: the probe¿s image has white lines coming up from the bottom of the screen.There is no error when the probe is plugged in.
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 conclusion of device evaluation has been updated from the initial medwatch, see below for correction.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 with no alleged deficiency reported.During evaluation, it was found the probe¿s image has white line coming up from the bottom of the screen due to an internal probe failure.A history review of serial number (b)(6) showed no other similar product complaint(s) from this serial number.H3 other text : evaluation findings are in section h.11.

• Brand Name: SITE~RITE 8 ULTRASOUND SYSTEM 20 MM PINPOINT GT
• 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: 11900794
• Report Number: 3006260740-2021-02080
• Device Sequence Number: 1403282
• Product Code: IYO
• UDI-Device Identifier: 00801741138195
• UDI-Public: (01)00801741138195
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/07/2021

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: 9770602X
• Device Catalogue Number: 9770602X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 05/28/2021
• Supplement Report FDA Received Date: 06/09/2021
• 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