MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SIRE-RITE 8 ULTRASOUND SYSTEM 32MM PROBE (REMANUFACTURED); SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 9770601Y

Device Problems No Display/Image (1183); Poor Quality Image (1408)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer, at this time, 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 been received, at this time.

Event Description

Picc rn reported system's ultrasound image is very dark.

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 dark ultrasound image was unconfirmed.The probe was evaluated with the model 550 phantom and the image was found to be normal.The root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.The device was serviced, tested, and returned to the customer.A history review of serial number (b)(6) showed no other similar product complaint(s) from this serial number.

Event Description

Picc rn reported system's ultrasound image is very dark.

• Brand Name: SIRE-RITE 8 ULTRASOUND SYSTEM 32MM PROBE (REMANUFACTURED)
• 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: 8067241
• MDR Text Key: 127222172
• Report Number: 3006260740-2018-03213
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741138317
• UDI-Public: (01)00801741138317
• Combination Product (y/n): N
• PMA/PMN Number: K152554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9770601Y
• Device Catalogue Number: 9770601Y
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Event Location: Hospital
• Date Manufacturer Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1