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

Model Number N/A

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 Description

Rn reported that the sr6 ultrasound system has a delay with the image when the needle is on.

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 sr6 ultrasound system has a delay with the image when the needle is on is unconfirmed.The scanner powers on and boots up normally.All needle tracking evaluations used the multipurpose vessel phantom and the sherlock test fixture.The scanner was attached to the sherlock, keyboard, usb stick and the printer.All evaluations showed normal functions and without any delays.The device was serviced, tested and returned to the customer.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.

Event Description

Rn reported that the sr6 ultrasound system has a delay with the image when the needle is on.

• Brand Name: REFURBISHED SITE~RITE 6 ULTRASOUND SYSTEM SCANNER
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7745423
• MDR Text Key: 116049252
• Report Number: 3006260740-2018-01937
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• PMA/PMN Number: K071204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 9770066R
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Event Location: Hospital
• Date Manufacturer Received: 05/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1