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

Model Number 9770086R

Device Problems Image Orientation Incorrect (1305); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2021

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

Per biomed, the image on the screen is flipped.Turned probe over and image is still flipped.

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 the image on the screen is flipped.Do not use gel caps.Turned probe over and image is still flipped was unconfirmed.The prevue was tested and functioned to manufacturing specifications.Attached is a picture using a needle guide showing that the image orientation is correct.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)(6) showed no other similar product complaint(s) from this serial number.

Event Description

Per biomed, the image on the screen is flipped.Turned probe over and image is still flipped.

• Brand Name: SITE~RITE PREVUE PLUS, REBURB.
• 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: 11467354
• MDR Text Key: 240441107
• Report Number: 3006260740-2021-00777
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741124945
• UDI-Public: (01)00801741124945
• Combination Product (y/n): N
• PMA/PMN Number: K120882
• 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: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9770086R
• Device Catalogue Number: 9770086R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Date Manufacturer Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other