MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE-RITE PREVUE; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number	9770090
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The manufacturer has received the sample and will be evaluated.Results are expected soon.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.
Event or Problem Description
Sales rep reported half of the screen remains black.
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 half of the screen remains black was confirmed.The root cause is determined to be due to a defective probe.The device was serviced, tested, and returned to the customer.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.
Event or Problem Description
Sales rep reported half of the screen remains black.

• Brand Name: SITE-RITE PREVUE
• Common Device Name: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7768183
• Report Number: 3006260740-2018-01982
• Device Sequence Number: 1793861
• Product Code: IYO
• UDI-Device Identifier: 00801741091056
• UDI-Public: (01)00801741091056
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K120882
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2019

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: 9770090
• Device Catalogue Number: 9770090
• Device Lot Number: N/I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Distributor Facility Aware Date: 07/18/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 06/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1