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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. BIOPSY DEVICE BIOPSY NEEDLE Back to Search Results
Lot Number REDS2594
Device Problems Misfire (2532); Activation, Positioning or Separation Problem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/08/2019
Event Type  malfunction  
Event Description
Pt was here for liver tx. Using a 16x16g bard biopsy device, while attempting to take specimen, the device misfired and needle did not deploy. The pa attempted to deploy needle outside of pt and the device still did not deploy; 16gx16g bard - lot # reds2594. Fda safety report id# (b)(4).
 
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Brand NameBIOPSY DEVICE
Type of DeviceBIOPSY NEEDLE
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
MDR Report Key8939622
MDR Text Key155986923
Report NumberMW5089375
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 08/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberREDS2594
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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