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

Catalog Number 9770066

Device Problems Break (1069); Failure to Align (2522)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

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.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 Description

It was reported by the bmet that the site rite 6 ultrasound and probe need evaluation/repair due possible misalignment of the image.Biomed mentioned the probe had some damage but could not recall where the damage was or if it was causing issues with the image alignment.

Manufacturer Narrative

H11:section a through f - the information provided by bd 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 bd.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 site rite 6 ultrasound and probe need evaluation/repair due possible misalignment of the image was unconfirmed.The scanner was evaluated using the multipurpose vessel phantom and the needle guide, the image were found to be aligned and normal for a site rite 6.The device was serviced, tested, and returned to the customer.A history review of serial number (b)(6) showed no other similar complaint(s) from this serial number.

Event Description

It was reported by the bmet that the site rite 6 ultrasound and probe need evaluation/repair due possible misalignment of the image.Biomed mentioned the probe had some damage but could not recall where the damage was or if it was causing issues with the image alignment.

• 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: 7807773
• MDR Text Key: 118232597
• Report Number: 3006260740-2018-02199
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741091049
• UDI-Public: (01)00801741091049
• 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: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• 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: 09/19/2018
• Event Location: Hospital
• Date Manufacturer Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1