MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE-RITE VISION II 40MM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Catalog Number	9770168
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will be evaluated.Results are expected soon.A lot history review (lhr) review is not possible, as the device is manufactured using a unique serial number and not by lot number.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.Evaluation in progress.
Event or Problem Description
It was reported that the probe is not giving a clear image.Moving the probe does produce a better image.
Event or Problem Description
It was reported that the probe is not giving a clear image.Moving the probe does produce a better 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 "probe is not giving a clear image" was unconfirmed, moving the probe does produce a better image.The probe was tested and functions normally.The device was tested, and returned to refurbished inventory.A lot history review (lhr) review is not possible, as the device is manufactured using a unique serial number and not by lot number.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.

• Brand Name: SITE-RITE VISION II 40MM
• 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: 8256964
• Report Number: 3006260740-2019-00036
• Device Sequence Number: 16623206
• Product Code: IYN
• UDI-Device Identifier: 00801741125331
• UDI-Public: (01)00801741125331
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2019

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 Catalogue Number: 9770168
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/27/2018
• Supplement Date Received by Manufacturer: 03/03/2019
• Initial Report FDA Received Date: 01/17/2019
• Supplement Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1