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 Problems Image Display Error/Artifact (1304); Poor Quality Image (1408)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device has not been received by the manufacturer, at this time, for evaluation.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.

Event Description

Per tm - there is a huge amount of raining interference in the image that cannot be removed with adjusting settings.

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 of the probe is producing rain like image on the screen is confirmed.The root cause of the reported issue is an internal probe failure.A history review of serial number (b)(6) showed no other similar product complaint(s) from this serial number.

Event Description

Per tm - there is a huge amount of raining interference in the image that cannot be removed with adjusting settings.

• 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
• MDR Report Key: 8877603
• MDR Text Key: 154009228
• Report Number: 3006260740-2019-02357
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741138201
• UDI-Public: (01)00801741138201
• Combination Product (y/n): N
• PMA/PMN Number: K152554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/18/2019
• Initial Date FDA Received: 08/09/2019
• Supplement Dates Manufacturer Received: 02/24/2020
• Supplement Dates FDA Received: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1