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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 BIOPSY INSTRUMENT

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BARD PERIPHERAL VASCULAR, INC. BARD TRUGUIDE DISPOSABLE COAXIAL BIOPSY NEEDLE BIOPSY INSTRUMENT Back to Search Results
Model Number C2010A
Device Problem Break (1069)
Patient Problem Injury (2348)
Event Date 05/28/2019
Event Type  Injury  
Manufacturer Narrative
The lot number for the device was provided. The device history records are currently under review. The device has been returned for evaluation. The investigation of the reported event is currently underway. (expiry date: 12/2021).
 
Event Description
It was reported that during a ct guided lung biopsy, the device allegedly broke off inside the patient. The patient was then transferred to the or where the device was successfully removed.
 
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Brand NameBARD TRUGUIDE DISPOSABLE COAXIAL BIOPSY NEEDLE
Type of DeviceBIOPSY INSTRUMENT
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V.
blvd montebello #1
parque industrial colonial
reynosa tamaulipas 88780
MX 88780
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key8725106
MDR Text Key148922157
Report Number2020394-2019-01140
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K936194
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberC2010A
Device Catalogue NumberC2010A
Device Lot NumberREDN4428
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2020
Was Device Evaluated by Manufacturer? Yes
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: 06/21/2019 Patient Sequence Number: 1
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