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

Model Number	9770116
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
It was reported by the bd tm that the sr 8 was on an mer stand and being maneuvered out of an elevator when the wheels caught on the elevator threshold and tipped over.When the system was evaluated it was noticed that there are two cuts in the probe cable.When the system is powered on the end users noted that there are several pronounced 'streaks' in the ultrasound image.
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 the system was evaluated it was noticed that there are two cuts in the probe cable was confirmed.The probe cable has two cuts and the image has dark vertical streaks.The root cause of the reported issue is use-related damage to the probe cable.No other functionality issues with the equipment were found during evaluation/servicing.The device was serviced, tested and returned to customer.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.
Event or Problem Description
It was reported by the bd tm that the sr 8 was on an mer stand and being maneuvered out of an elevator when the wheels caught on the elevator threshold and tipped over.When the system was evaluated it was noticed that there are two cuts in the probe cable.When the system is powered on the end users noted that there are several pronounced 'streaks' in the ultrasound image.

• Brand Name: SITE-RITE 8 ULTRASOUND
• 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: 7693707
• Report Number: 3006260740-2018-01731
• Device Sequence Number: 1015582
• Product Code: IYO
• UDI-Device Identifier: 00801741124693
• UDI-Public: (01)00801741124693
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K152554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2019

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: 9770116
• Device Catalogue Number: 9770501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1