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

Catalog Number 9770066

Device Problem Device Operates Differently Than Expected (2913)

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

Customer reported the system's contrast is too bright and as a result, the depth of the needle cannot be visualized.

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 system's contrast is too bright was unconfirmed.The scanner powers on and boots up normally.The scanner brightness' was turned off, the gain was set to 65%, the depth was set to 3.0cm and the smooth/sharp' image was set to sharp.' the image of the needle depth was normal.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 Description

Customer reported the system's contrast is too bright and as a result, the depth of the needle cannot be visualized.

• Brand Name: SITE~RITE 6 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: 7501097
• MDR Text Key: 107965539
• Report Number: 3006260740-2018-00952
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9770066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Event Location: Hospital
• Date Manufacturer Received: 03/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1