MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SITE-RITE 8 ULTRASOUND SYSTEM CONSOLE (REMANUFACTURED); SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number N/A

Device Problems Computer Software Problem (1112); Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/13/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned 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

Per sales rep - something is not functioning properly with the ultrasound software.There was the previously described issue of shutting off while plugged in and ec 111 appearing.This was during a picc insertion.

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 ec111 error was confirmed.Although the error did not occur during the assessment, it was found in the logs that the ec111 error was displayed.The root cause is due to a general system error.The sr8 will be re-imaged to clear the error.H3 other text : evaluation findings are in section h.11.

Event Description

Per sales rep - something is not functioning properly with the site rite 8 software.There was the previously described issue of shutting off while plugged in and ec 111 appearing.This was during a picc insertion.

• Brand Name: SITE-RITE 8 ULTRASOUND SYSTEM CONSOLE (REMANUFACTURED)
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): DYMAX CORP. -2523003; 110 marshall drive; warrendale PA 15086
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12587006
• MDR Text Key: 275135132
• Report Number: 3006260740-2021-04166
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741138287
• UDI-Public: (01)00801741138287
• 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: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• 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: 9770600Y
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2021
• 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
• Removal/Correction Number: 2243072-10/11/2019-013-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other