MAUDE Adverse Event Report: BARD ACCESS SYSTEMS VISION II 64 ELEMENT PROBE; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Catalog Number	9770169
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 device has not been returned to the manufacturer, at this time, for evaluation.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 sales rep on behalf of the picc rn that the vision ii ultrasound 20mm linear probe strain relief is torn.The image sent shows exposed cable wires as a result of the physical damage.

• Brand Name: VISION II 64 ELEMENT 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: 7873266
• Report Number: 3006260740-2018-02432
• Device Sequence Number: 11275147
• Product Code: IYN
• UDI-Device Identifier: 00801741125348
• UDI-Public: (01)00801741125348
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K132942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2018

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: 9770169
• 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: 09/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1