MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE-RITE 5 PROBE; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Catalog Number 9760034

Device Problem Display or Visual Feedback Problem (1184)

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

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation, as the device is being retained by the reporting facility.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

Philips healthcare biomed reported that sr5 probe sn (b)(4) shows dark shadowing in the acoustic image on a sr 5 scanner.

• Brand Name: SITE-RITE 5 PROBE
• 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: kizi zaccaria ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225594
• MDR Report Key: 7807774
• MDR Text Key: 118102783
• Report Number: 3006260740-2018-02200
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00801741125720
• UDI-Public: (01)00801741125720
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/22/2018

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: 9760034
• 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