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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD REYNOSA S.A. DE C.V. TRUGUIDE COAXIAL BIOPSY NEEDLE BIOPSY INSTRUMENT

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BARD REYNOSA S.A. DE C.V. TRUGUIDE COAXIAL BIOPSY NEEDLE BIOPSY INSTRUMENT Back to Search Results
Model Number C1810A
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem Injury (2348)
Event Date 04/05/2019
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed. The device has been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway.
 
Event Description
It was reported that during a ct-guided biopsy of a cirrhotic liver of normal density, the needle of the device allegedly broke off inside the patient after the procedure was completed. It was further reported that the needle was surgically removed from the patient. The patient is reportedly fine.
 
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Brand NameTRUGUIDE COAXIAL BIOPSY NEEDLE
Type of DeviceBIOPSY INSTRUMENT
Manufacturer (Section D)
BARD REYNOSA S.A. DE C.V.
blvd montebello #1
parque industrial colonial
reynosa tamaulipas 88780
MX 88780
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 Key8578726
MDR Text Key143993982
Report Number2020394-2019-00540
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K936194
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 11/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2020
Device Model NumberC1810A
Device Catalogue NumberC1810A
Device Lot NumberRECZ1117
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/10/2019
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: 05/03/2019 Patient Sequence Number: 1
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