MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE-RITE 8 ULTRASOUND SYSTEM 20MM PINPOINT GT PROBE (REMANUFACTURED); SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 9770602Y

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer, at this time, for evaluation.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.

Event Description

It was reported the gt function on the probe is not picking up the gt needle properly.

• Brand Name: SITE-RITE 8 ULTRASOUND SYSTEM 20MM PINPOINT GT PROBE (REMANUFACTURED)
• 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: 8181403
• MDR Text Key: 130990892
• Report Number: 3006260740-2018-03617
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741138201
• UDI-Public: (01)00801741138201
• 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,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9770602Y
• Device Catalogue Number: 9770602Y
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 11/28/2018
• 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