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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRACOR TWIRL MARKER BIOPSY INSTRUMENT

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BARD PERIPHERAL VASCULAR, INC. ULTRACOR TWIRL MARKER BIOPSY INSTRUMENT Back to Search Results
Model Number UCTW17
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Reaction (2414)
Event Date 04/23/2020
Event Type  Injury  
Manufacturer Narrative
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. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device. Upon receipt of new or additional information, a follow-up report will be submitted as applicable. (expiry date: 03/2022).
 
Event Description
It was reported that after placement of breast tissue marker, the patient allegedly experienced redness and swelling at the insertion site. The device has not been removed but is scheduled to be removed at a later date. The current patient's status is unknown.
 
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Brand NameULTRACOR TWIRL MARKER
Type of DeviceBIOPSY INSTRUMENT
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
BARD SHANNON LIMITED
san geronimo industrial park
lot #1, road #3, km 79.7
humacao 00791
00791
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key10077202
MDR Text Key191628898
Report Number2020394-2020-03449
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K152510
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 10/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUCTW17
Device Catalogue NumberUCTW17
Device Lot NumberHUDR1745
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 Received09/29/2020
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: 05/20/2020 Patient Sequence Number: 1
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