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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP BARRX BEACON KIT, NEEDLE, BIOPSY

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COVIDIEN LP BARRX BEACON KIT, NEEDLE, BIOPSY Back to Search Results
Model Number F-22-05
Device Problem Insufficient Information (3190)
Patient Problem Radiation Exposure, Unintended (3164)
Event Date 01/04/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during the endoscopic ultrasound-guided fiducial placement, the physician tried to verify the fiducial placement using endoscopic ultrasound and x-ray, but fiducials were not visible. They used another needle to complete the procedure. The needle will be returned for investigation. The patient was prepped for the procedure and was under anesthesia, no repeat procedure was necessary, and there was no user harm.
 
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Brand NameBEACON
Type of DeviceKIT, NEEDLE, BIOPSY
Manufacturer (Section D)
COVIDIEN LP BARRX
covidien gi solutions
sunnyvale CA 94085 4022
Manufacturer (Section G)
COVIDIEN LP BARRX
covidien gi solutions
sunnyvale CA 94085 4022
Manufacturer Contact
amy beeman
161 cheshire lane, suite 100
plymouth, MN 55441
7632104064
MDR Report Key8331159
MDR Text Key135873789
Report Number3004904811-2019-00005
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/01/2020
Device Model NumberF-22-05
Device Catalogue NumberF-22-05
Device Lot NumberB000000657
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2018
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: 02/12/2019 Patient Sequence Number: 1
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