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

Model Number N/A

Device Problems Display or Visual Feedback Problem (1184); Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A history review of serial number (b)(4) showed one other similar product complaint(s) from this serial number.

Event Description

Per picc team - broken crystals in the probe, there is a black mark on the screen at all times.

Event Description

Per picc team - broken crystals in the probe, there is a black mark on the screen at all times.

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 broken crystals in the probe, there is a black mark on the screen at all times was confirmed.The root cause of the reported issue was identified as a probe failure.The site rite 8 20mm gt probe was visually inspected upon receipt and was found to be in good physical condition.A history review of serial number (b)(6) showed one other similar product complaint(s) from this serial number.

• Brand Name: SITE~RITE 8 ULTRASOUND SYSTEM 20 MM PINPOINT GT
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• MDR Report Key: 9888230
• MDR Text Key: 194621611
• Report Number: 3006260740-2020-01089
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741138324
• UDI-Public: (01)00801741138324
• 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: 05/15/2020

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: 9770602
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/03/2020
• Initial Date FDA Received: 03/27/2020
• Supplement Dates Manufacturer Received: 04/28/2020
• Supplement Dates FDA Received: 05/15/2020
• 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