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

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

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

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

Event Description

It was reported by the picc team to the bas tm that since product receipt the sr 8 w/pinpoint gt technology (b)(4) has a lag in the ultrasound image.The team has since stopped using the system due to the delay in live ultrasound image.It was also reported to the bas cns that "needle never shows up w the needle guide.".

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, trend analysis, 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 reported issue of ultrasound image lag on the sr8 was confirmed at the service facility.The customer video showed a delay in the live ultrasound image and the delay was also observed during investigation.However, the root cause of the image delay could not be determined.The sr8 was re-imaged as a precaution and the delay was no longer observed.The manufacture site reported the scanner passed functional testing requirements.Manufacturing records were reviewed and no potential contributing factors were found during manufacture and quality inspection of the device.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.

Event Description

It was reported by the picc team to the bas tm that since product receipt the sr 8 w/pinpoint gt technology sn: (b)(4) has a lag in the ultrasound image.The team has since stopped using the system due to the delay in live ultrasound image.It was also reported to the bas cns that "needle never shows up w the needle guide." additional information: users have "complained of blowing the veins due to visualization issues of the delay.".

• 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. -2523003; 110 marshall drive; warrendale PA 15086
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 7294189
• MDR Text Key: 101153326
• Report Number: 3006260740-2018-00286
• 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: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 9770501
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 08/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1