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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE-RITE PREVUE; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

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BARD ACCESS SYSTEMS SITE-RITE PREVUE; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number 9770090
Device Problem Failure to Align (2522)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will be evaluated.Results are expected soon.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.
 
Event Description
Per biomed from user the probe is out of alignment while using gel caps.
 
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 the probe is out of alignment while using gel caps is unconfirmed.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
Per biomed from user the probe is out of alignment while using gel caps.
 
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Brand Name
SITE-RITE PREVUE
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 Key8637710
MDR Text Key146062105
Report Number3006260740-2019-01467
Device Sequence Number1
Product Code IYO
UDI-Device Identifier00801741091056
UDI-Public(01)00801741091056
Combination Product (y/n)N
PMA/PMN Number
K120882
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 07/03/2019
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 Number9770090
Device Catalogue Number9770090
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/08/2019
Initial Date Manufacturer Received 04/30/2019
Initial Date FDA Received05/23/2019
Supplement Dates Manufacturer Received06/04/2019
Supplement Dates FDA Received07/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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