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U.S. Department of Health and Human Services

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

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C.R. BARD, INC. (BASD) -3006260740 SITE-RITE 8 ULTRASOUND SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number 9770501
Device Problems Break (1069); Material Frayed (1262)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/21/2020
Event Type  malfunction  
Manufacturer Narrative
A replacement battery was sent to the reporting facility. Therefore, the device will not be returned for evaluation. A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number. Device not returned for evaluation.
 
Event Description
Per picc nurse, power cord is frayed and wired exposed.
 
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Brand NameSITE-RITE 8 ULTRASOUND
Type of DeviceSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
MDR Report Key10669701
MDR Text Key212513726
Report Number3006260740-2020-20071
Device Sequence Number1
Product Code IYO
Combination Product (y/n)N
PMA/PMN Number
K152554
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial
Report Date 09/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9770501
Device Catalogue Number9770501
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 10/13/2020 Patient Sequence Number: 1
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