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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR BIOPSY PROBE; BIOPSY INSTRUMENT
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BARD PERIPHERAL VASCULAR, INC. ENCOR BIOPSY PROBE; BIOPSY INSTRUMENT Back to Search Results
Model Number ECP017GV
Device Problems Suction Problem (2170); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/16/2020
Event Type  malfunction  
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.The investigation of the reported event is currently underway.Expiry date (10/2021).
 
Event Description
It was reported that during an ultrasound-guided breast biopsy procedure through fibroadenoma tissue, the device allegedly had suction issue.The procedure was completed using another device.There was no reported patient injury.
 
Event Description
It was reported that during an ultrasound-guided breast biopsy procedure through fibroadenoma tissue, the device allegedly had suction issue.The procedure was completed using another device.There was no reported patient injury.
 
Manufacturer Narrative
H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: d4 (expiry date: 10/2021), h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
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Brand Name
ENCOR BIOPSY PROBE
Type of Device
BIOPSY INSTRUMENT
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key11371460
MDR Text Key233242803
Report Number2020394-2021-00318
Device Sequence Number1
Product Code KNW
UDI-Device Identifier00801741086298
UDI-Public(01)00801741086298
Combination Product (y/n)N
PMA/PMN Number
K051158
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberECP017GV
Device Catalogue NumberECP017GV
Device Lot NumberVTDX0714
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2021
Date Manufacturer Received03/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Weight50
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