MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE-RITE 5 PROBE; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Catalog Number	9760034
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation, as the device is being retained by the reporting facility.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.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.
Event or Problem Description
Philips healthcare biomed reported that sr5 probe sn (b)(4) shows dark shadowing in the acoustic image on a sr 5 scanner.

• Brand Name: SITE-RITE 5 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: 7807774
• Report Number: 3006260740-2018-02200
• Device Sequence Number: 11444765
• Product Code: ITX
• UDI-Device Identifier: 00801741125720
• UDI-Public: (01)00801741125720
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K052517
• 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
• Report Date (Section B): 08/22/2018

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: 9760034
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1