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

Model Number 9770501

Device Problem Product Quality Problem (1506)

Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)

Event Type  Injury  

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 for evaluation.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 vat rn that the needle visualization on the site rite 8 is poor.The rn uses the system for training on picc, accucath and midlines and finds it very difficult to train when the needle echo is not present when used on a vein block or patient.As a result of the poor needle visualization the rn's in training have been documented to hit arteries, nerves, caused vessels to bleed yet site rite 8 indicated a successful vascular access obtained in about 50% of the attempts.The rn stated image quality is fine for most end users and he can visualize the vascular structure and other shallow anatomical structures but when free-handing a catheter placement and looking for the indentation of the vascular structure puts the needle too close to the structure to avoid impact or injury to the targeted structure.

• 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.; 141 zehner school road; zelienople PA 16063
• Manufacturer Contact: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 7899675
• MDR Text Key: 121436719
• Report Number: 3006260740-2018-02544
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741098338
• UDI-Public: (01)00801741098338
• 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: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9770501
• Device Catalogue Number: 9770501
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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