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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS REFURB, SR PREVUE PLUS; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

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BARD ACCESS SYSTEMS REFURB, SR PREVUE PLUS; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number 9770086R
Device Problem Failure to Align (2522)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The device has not been received by 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
Per clinical tech services, alignment is 'off'.
 
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 initial complaint appeared to be a reportable occurrence.Once the sample was returned and evaluated it was determined, that the information provided does not reasonably suggest the event may have caused or contributed to a death or serious injury of a patient, user or other person.Therefore, this event is deemed not reportable per 21 cfr part 803.
 
Event Description
Per clinical tech services, alignment is 'off'.
 
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Brand Name
REFURB, SR PREVUE PLUS
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 Key8700332
MDR Text Key148075946
Report Number3006260740-2019-01671
Device Sequence Number1
Product Code IYO
UDI-Device Identifier00801741124945
UDI-Public(01)00801741124945
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 08/05/2019
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 Number9770086R
Device Catalogue Number9770086R
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/30/2019
Event Location Hospital
Initial Date Manufacturer Received 05/23/2019
Initial Date FDA Received06/14/2019
Supplement Dates Manufacturer Received07/17/2019
Supplement Dates FDA Received08/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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