MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE~RITE 8 ULTRASOUND SYSTEM 20 MM PINPOINT GT; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 9770602

Device Problems Defective Component (2292); Computer Operating System Problem (2898)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Per picc team and dm: probe froze during use.The picture was very dark despite changing settings.They also restarted the ultrasound, unplugged and plugged in again the probe without change.

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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.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 site rite 8 was visually inspected upon receipt and was found to be in good physical condition.The probe is giving a poor image.The probe's image is rainy , there is no external damage on the probe.The probe is giving a poor image due to an internal failure of the probe.H3 other text : see h.11 for evaluation conclusion.

Event Description

Per picc team and dm: probe froze during use.The picture was very dark despite changing settings.They also restarted the ultrasound, unplugged and plugged in again the probe without change.

• Brand Name: SITE~RITE 8 ULTRASOUND SYSTEM 20 MM PINPOINT GT
• 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.; 141 zehner school road; zelienople PA 16063
• Manufacturer Contact: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 8927607
• MDR Text Key: 155510822
• Report Number: 3006260740-2019-02496
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741138324
• UDI-Public: (01)00801741138324
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/08/2022

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: 9770602
• Device Catalogue Number: 9770602
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/01/2019
• Initial Date FDA Received: 08/23/2019
• Supplement Dates Manufacturer Received: 08/01/2019
• Supplement Dates FDA Received: 04/08/2022
• 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