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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MARQUEE; BIOPSY INSTRUMENT
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BARD PERIPHERAL VASCULAR, INC. MARQUEE; BIOPSY INSTRUMENT Back to Search Results
Catalog Number MQ1410
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/20/2023
Event Type  malfunction  
Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiry date: 04/2026).H11: section a through f: the information provide by bd represents all 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.
 
Event Description
It was reported that during an ultrasound guided breast biopsy through dense tissue, the cannula allegedly completely detached from the device while firing in the breast tissue and got stuck in the patient.Reportedly, the cannula was able to be retrieved.The procedure was completed using another device.There was no reported patient injury.
 
Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one marquee disposable core biopsy instrument and the detached cannula received for evaluation.On visual evaluation the device was received without productive tubing in half energized position with the sample notch visible and have residue throughout the device.It was noted that the cannula was detached from the device.Due to the condition of the received sample, functional testing was not performed.Therefore, the investigation of the reported detachment was confirmed as the detachment was noted in the evaluation.A definitive root cause for the reported detachment of device or device component could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiry date: 04/2026), g3.H11: section a through f: the information provide by bd represents all 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.
 
Event Description
It was reported that during an ultrasound guided breast biopsy through dense tissue, the cannula allegedly completely detached from the device while firing in the breast tissue and got stuck in the patient.Reportedly, the cannula was able to be retrieved.The procedure was completed using another device.There was no reported patient injury.
 
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Brand Name
MARQUEE
Type of Device
BIOPSY INSTRUMENT
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
CAREFUSION D.R. 203 LTD.
zona franca las americas
km 22-e-1
santo domingo 11606
DR   11606
Manufacturer Contact
brett curtice
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key17937306
MDR Text Key326153110
Report Number2020394-2023-00864
Device Sequence Number1
Product Code KNW
UDI-Device Identifier00801741097133
UDI-Public(01)00801741097133
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133948
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberMQ1410
Device Lot Number0001516487
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/15/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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