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

Model Number N/A

Device Problems Device Stops Intermittently (1599); Malposition of Device (2616); Application Program Problem (2880); Noise, Audible (3273)

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 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.Device has not yet been returned for evaluation.

Event Description

Per biomed, site rite 8 (b)(4) - end users are complaining that sr 8 system is making a random beeping noise that they cannot pinpoint where it is coming from.System's battery is full when beeping occurs.They also reported that the touch screen is intermittently non-functional.Nurse also reported that during one procedure, while advancing the picc in sherlock mode, the green diamond never appeared to indicate that they were in the correct position.This caused the user to place the picc too far.Confirmation was done through cxr.

Event Description

Per biomed, site rite 8 (sn (b)(4)) - end users are complaining that sr 8 system is making a random beeping noise that they cannot pinpoint where it is coming from.System's battery is full when beeping occurs.They also reported that the touch screen is intermittently non-functional.Nurse also reported that during one procedure, while advancing the picc in sherlock mode, the green diamond never appeared to indicate that they were in the correct position.This caused the user to place the picc too far.Confirmation was done through cxr.

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: the device was returned to the service facility for evaluation.During evaluation, the reported issue of inaccurate ecg readings was unconfirmed.The sherlock software was tested with an internal use sherlock sensor and sherlock test fixture; the green diamond did appear during this test.The customer sherlock is not with the system for a complete test.The root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.No other functionality issues with the equipment were found during evaluation/servicing.The device was serviced, tested, and returned to the customer.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.

• 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
• MDR Report Key: 7367579
• MDR Text Key: 103532707
• Report Number: 3006260740-2018-00520
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741096891
• UDI-Public: (01)00801741096891
• 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: 08/30/2019

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: N/A
• Device Catalogue Number: 9770500
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/23/2018
• Supplement Dates Manufacturer Received: 08/29/2019
• Supplement Dates FDA Received: 08/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1