MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE~RITE 8 ULTRASOUND SYSTEM (USA); SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 9770500

Device Problem Poor Quality Image (1408)

Patient Problem No Information (3190)

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 manufacturer has received the sample and will be evaluated.Results are expected soon.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.

Event Description

Rn reported ultrasound image on sr8 scanner looks grainy.

Manufacturer Narrative

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: during evaluation, the reported grainy ultrasound image issue could not be reproduced.The scanner was evaluated with the model 550 phantom (b)(4) and the image was found to be normal for a sr 8 scanner with the 32 mm probe.The root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.The review of the dhr, sub-assembly dhr, sub-assembly manufacturing, component records, manufacturing process changes, mrr/mrb, and internal rejects showed that the reported issue is not likely related to a manufacturing issue.No other functionality issues with the equipment were found during evaluation.The sr8 was serviced, qc tested, and returned to the customer.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.

Event Description

Rn reported ultrasound image on sr8 scanner looks grainy.

• Brand Name: SITE~RITE 8 ULTRASOUND SYSTEM (USA)
• 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: sydney freckleton ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225992
• MDR Report Key: 7711264
• MDR Text Key: 114867432
• Report Number: 3006260740-2018-01788
• Device Sequence Number: 1
• Product Code: ITX
• 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: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9770500
• Device Catalogue Number: 9770500
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 09/10/2018
• 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