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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD PERIPHERAL INTERVENTION ULTRACLIP II MARKER BIOPSY INSTRUMENT

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BD PERIPHERAL INTERVENTION ULTRACLIP II MARKER BIOPSY INSTRUMENT Back to Search Results
Model Number 864017
Device Problem Signal Artifact/Noise (1036)
Patient Problem Injury (2348)
Event Date 08/07/2019
Event Type  Injury  
Manufacturer Narrative
This event is being reported as a reportable malfunction for the special cause related to these product catalog/lot number combinations which is the subject of report of corrections and removal letter (806 notification) on may 2, 2019. As the lot number for the device was provided, a manufacturing review will be performed. The sample was not returned to the manufacturer for inspection/evaluation, however an image was provided for review. The investigation is currently underway. Expiry date (09/2021).
 
Event Description
It was reported that after placement of the device, it allegedly created a significant artifact under mri. It was further reported that this artifact allegedly hid the enhancement from a small, previously placed, cancer clip. The current patient status is unknown.
 
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Brand NameULTRACLIP II MARKER
Type of DeviceBIOPSY INSTRUMENT
Manufacturer (Section D)
BD PERIPHERAL INTERVENTION
1415 w. 3rd street
tempe AZ 85281
Manufacturer (Section G)
BARD SHANNON LIMITED
san geronimo industrial park
lot #1, road #3, km 79.7
humacao 00791
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key9137750
MDR Text Key160770009
Report Number2020394-2019-03636
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K063238
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number864017
Device Catalogue Number864017
Device Lot NumberHUCX0340
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/30/2019 Patient Sequence Number: 1
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