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

Catalog Number	9770500R
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will be evaluated.Results are expected soon.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.
Event or Problem Description
Per picc nurse: the unit was plugged in and had 78% power but just shutdown and would not reboot for more than 5 minutes.
Event or Problem Description
Per picc nurse: the unit was plugged in and had 78% power but just shutdown and would not reboot for more than 5 minutes.
Additional 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 abrupt shutdown was confirmed.The scanner was charged to 100%, when the ac adaptor was removed the scanner ran on battery power for approximately 30 minutes.The root cause is an internal failure in the lithium-ion battery.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.
Event or Problem Description
Per picc nurse: the unit was plugged in and had 78% power but just shutdown and would not reboot for more than 5 minutes.
Additional Manufacturer Narrative
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 abrupt shutdown was confirmed.The scanner was charged to 100%, when the ac adaptor was removed the scanner ran on battery power for approximately 30 minutes.The root cause is an internal failure in the lithium-ion battery.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: REFURB, SITE-RITE 8
• Common Device Name: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8380507
• Report Number: 3006260740-2019-00435
• Device Sequence Number: 1651618
• Product Code: IYO
• UDI-Device Identifier: 10801741104128
• UDI-Public: (01)10801741104128
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 9770500R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/09/2019
• Supplement Date Received by Manufacturer: 05/03/2019; 10/11/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 05/21/2019; 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2243072-10/11/2019-013-C
• Patient Sequence Number: 1