MAUDE Adverse Event Report: BARD ACCESS SYSTEMS REFURB, SITE-RITE 8; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 system displays a hazy, poor image quality that is extremely blurry and "convoluted".
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 ultrasound image quality was unconfirmed as the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.The scanner was evaluated with the model 550 phantom (t11900271) and the image was found to be normal for a sr 8 scanner with the 20 mm gt probe.No other functionality issues with the equipment were found during evaluation/servicing.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 system displays a hazy, poor image quality that is extremely blurry and "convoluted".

• Brand Name: REFURB, SITE-RITE 8
• 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: 7661074
• Report Number: 3006260740-2018-01623
• Device Sequence Number: 11023077
• Product Code: IYO
• UDI-Device Identifier: 10801741104128
• UDI-Public: (01)10801741104128
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2019

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: Other
• Device Model Number: N/A
• Device Catalogue Number: 9770500R
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 08/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1