MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE~RITE 6 PROBE; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Catalog Number	9770001
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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported by the facility that there is a "drop-out" on the image with the site rite 6 probe (sn:(b)(4)) with black lines down the screen.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, 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 complaint of ultrasound image drop-out/poor image quality was confirmed upon evaluation of the sr6 probe at the service facility.It was found that the probe was cracked in two areas on the nose housing and there was nose separation with multiple open probe elements.The root cause of the probe damaged is likely use-related damage.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported by the facility that there is a "drop-out" on the image with the site rite 6 probe (sn:(b)(4)) with black lines down the screen.

• Brand Name: SITE~RITE 6 PROBE
• 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: 7289846
• Report Number: 3006260740-2018-00259
• Device Sequence Number: 13756194
• Product Code: IYO
• UDI-Device Identifier: 00801741125744
• UDI-Public: (01)00801741125744
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K071204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2018

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 Catalogue Number: 9770001
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1