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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DISPOSABLE COAXIAL BIOPSY NEEDLE

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BARD PERIPHERAL VASCULAR, INC. DISPOSABLE COAXIAL BIOPSY NEEDLE Back to Search Results
Catalog Number C2020A
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 11/03/2021
Event Type  malfunction  
Event Description
Biopsy needle broke off at hub inside of patient's lower back. Presence of the needle remnant within the right buttock. This was removed at the time of the procedure. Fda safety report id # (b)(4).
 
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Brand NameDISPOSABLE COAXIAL BIOPSY NEEDLE
Type of DeviceBIOPSY NEEDLE
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
tempe AZ 85281
MDR Report Key12813644
MDR Text Key280935200
Report NumberMW5105298
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 Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberC2020A
Device Lot NumberREFQ3217
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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