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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. BARD MAGNUM DISPOSABLE BY NEEDLE BIOPSY NEEDLE 18GX20CM

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BARD PERIPHERAL VASCULAR, INC. BARD MAGNUM DISPOSABLE BY NEEDLE BIOPSY NEEDLE 18GX20CM Back to Search Results
Model Number MN1820
Device Problem Device Fell (4014)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/10/2019
Event Type  malfunction  
Event Description
The dr did a prostate biopsy on 07/10/2019. On the 12th core, we did not get a specimen, we tried twice more and on the last one. As the dr tried to unload the core, small pieces of pink plastic fell out of the device. We replaced the needle and finished the exam. This issue happened again on (b)(6) 2019 except on the first try, this also happened the 3rd week in (b)(6) with three needles. We sent pictures of the needles to bard on these three. It also happened in (b)(6) and i kept that needle and sent it to bard. After talking to our bard rep, we did get 4 replacement needles, but no explanation of the problem. This problem subjects the pt to add'l biopsies which increase the risk of infection to the pt.
 
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Brand NameBARD MAGNUM DISPOSABLE BY NEEDLE
Type of DeviceBIOPSY NEEDLE 18GX20CM
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 west 3rd street
tempe AZ 85281
MDR Report Key8879243
MDR Text Key154315483
Report NumberMW5088908
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 Radiologic Technologist
Type of Report Initial
5 Devices were Involved in the Event: 1   2   3   4   5  
0 Patients were Involved in the Event:
Date FDA Received08/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2021
Device Model NumberMN1820
Device Catalogue NumberMN1820
Device Lot NumberREDP0415
Was Device Available for Evaluation? Yes
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? No
Type of Device Usage

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