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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR INC BARD TRUGUIDE DISPOSABLE COAXIAL BIOPSY NEEDLE Back to Search Results
Catalog Number C@) 16A
Device Problems Difficult to Insert (1316); Material Twisted/Bent (2981)
Patient Problem Pain (1994)
Event Date 08/28/2018
Event Type  malfunction  
Event Description
While attempting to perform a liver biopsy under ct guidance, the pt complained of pain, radiologist attempted to inject add'l lidocaine through the device, there was an obstruction, so the radiologist attempted to insert stylet to advance needle but stylet would not properly insert into device. The radiologist instructed staff to obtain a ct image and at that time, it was discovered that the device had a 90 degree bend near the end of the needle. The device was removed without incident or injury to the pt. Attempt to obtain a liver sample was discontinued and biopsy rescheduled for a future date. (b)(4) at bard contacted (b)(4) 2018 (b)(4) and he will send a bio-hazard container to (b)(6) mgr to send the device back to the mfr.
 
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Brand NameBARD TRUGUIDE
Type of DeviceDISPOSABLE COAXIAL BIOPSY NEEDLE
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR INC
tempe AZ
MDR Report Key7865375
MDR Text Key120299831
Report Number7865375
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 User Facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 08/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2020
Device Catalogue NumberC@) 16A
Device Lot NumberREBW1669
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date08/28/2018
Device Age1 YR
Event Location Hospital
Date Report to Manufacturer08/29/2018
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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