MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SITE~RITE 8 ULTRASOUND SYSTEM 32MM LINEAR PROBE REFURBISHED; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 9770600X

Device Problems No Display/Image (1183); Image Display Error/Artifact (1304)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/29/2020

Event Type  malfunction  

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 no other similar product complaint(s) from this serial number.

Event Description

Found during evaluation: there is a black line in the middle of the ultrasound image.

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 with no alleged deficiency reported.During evaluation, it was found the system has a dark black line through the middle of the ultrasound image.The root cause of the failure was identified as a damaged beamformer connector pcb.A history review of serial number (b)(6) showed no other similar product complaint(s) from this serial number.

Event Description

Found during evaluation: there is a black line in the middle of the ultrasound image.

• Brand Name: SITE~RITE 8 ULTRASOUND SYSTEM 32MM LINEAR PROBE REFURBISHED
• Type of Device: 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: 10880124
• MDR Text Key: 218264380
• Report Number: 3006260740-2020-20622
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741138270
• UDI-Public: (01)00801741138270
• Combination Product (y/n): N
• PMA/PMN Number: K152554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/02/2021

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
• Device Operator: Health Professional
• Device Model Number: 9770600X
• Device Catalogue Number: 9770600X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 03/02/2021
• Supplement Dates FDA Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other