MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE-RITE 8 ULTRASOUND; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number N/A

Device Problem Poor Quality Image (1408)

Patient Problem Perforation of Vessels (2135)

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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.Device not yet returned.

Event Description

It was reported by the picc rn that was having difficulty obtaining a vascular image on the site rite 8 ultrasound base system.The rn stated that she is unable to visualize an image of a vascular structure and if she does get an image, then it will often "disappear." it was said that intermittently the ultrasound image and/or the echo of the needle would suddenly be lost in the middle of a scan.Due to the inability to properly view an image the rn reported that she punctured an artery with the needle while she was in the brachial vein.She stated she has also come close to puncturing a nerve bundle.It was stated the poor image quality delays sticks and often the rn will abort the procedure with the site rite 8 and perform a "blind stick" instead of relying on the ultrasound.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, trend analysis, 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 complaint of poor image quality could not be reproduced at the service facility.The service facility/manufacturer site reported that the scanner passed functional testing requirements during evaluation.Manufacturing records were also reviewed and no potential contributing factors were found during manufacture and quality inspection of the device.The returned system did not display the behavior reported by the complainant and it is likely that the event was caused by another root cause.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.

Event Description

It was reported by the picc rn that was having difficulty obtaining a vascular image on the site rite 8 ultrasound base system.The rn stated that she is unable to visualize an image of a vascular structure and if she does get an image, then it will often "disappear." it was said that intermittently the ultrasound image and and/or the echo of the needle would suddenly be lost in the middle of a scan.Due to the inability to properly view an image the rn reported that she punctured an artery with the needle while she was in the brachial vein.She stated she has also come close to puncturing a nerve bundle.It was stated the poor image quality delays sticks and often the rn will abort the procedure with the site rite 8 and perform a "blind stick" instead of relying on the ultrasound.

• Brand Name: SITE-RITE 8 ULTRASOUND
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): DYMAX CORP. -2523003; 110 marshall drive; warrendale PA 15086
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 7119756
• MDR Text Key: 95073813
• Report Number: 3006260740-2017-02238
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741096891
• UDI-Public: (01)00801741096891
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• 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: 9770500
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 05/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1