MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MARQUEE; BIOPSY INSTRUMENT

Model Number	MQK1410
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ultrasound guided breast biopsy procedure, the needle allegedly stuck when attempting to remove from coaxial.The procedure was completed without using the coaxial.There was no reported patient injury.
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that during an ultrasound guided breast biopsy procedure, the needle allegedly got stuck with the coaxial.The procedure was completed using the same device without using coaxial introducer.There was no reported patient injury.
Additional Manufacturer Narrative
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: the manufacturing location was selected as unknown due to system limitations.The manufacturing location for this product is bd-santo domingo.The information provided 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.

• Brand Name: MARQUEE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): UNKNOWN; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR ; BR
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16644548
• Report Number: 2020394-2023-00211
• Device Sequence Number: 6157627
• Product Code: KNW
• UDI-Device Identifier: 00801741097287
• UDI-Public: (01)00801741097287
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K133948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MQK1410
• Device Catalogue Number: MQK1410
• Device Lot Number: 0001441329
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown