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

Model Number	MQ1413
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A voluntary recall has been initiated for the bard® marquee® disposable core biopsy instruments and instrument kits which was product catalog/lot number specific.Reportedly the penetration depth switch used to select the desired penetration depth of the biopsy needle for soft tissue biopsies, detaches from the device during use.The penetration depth switch detachments may result in (1) prolongation of the biopsy procedures as the user obtains a replacement device, (2) undershooting the lesion unsuspectedly, compromising the sample quality and potentially leading to a misdiagnosis (3) or if the penetration is overshot, the device may pierce adjacent tissue and/or organs causing injury.To date, there have been no reported patient injuries associated with these penetration depth switch detachments.As a result of the field action, this event is being reported as a malfunction reportable event.The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The manufacturing location was selected as unknown due to system limitations.The manufacturing location for this product is bd-santo domingo.(expiry date: 03/2023).
Event or Problem Description
It was reported that prior to a biopsy procedure, the device button allegedly fell off.There was no patient contact.

• Brand Name: MARQUEE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11492235
• Report Number: 2020394-2021-00569
• Device Sequence Number: 5373974
• Product Code: KNW
• UDI-Device Identifier: 00801741097140
• UDI-Public: (01)00801741097140
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K133948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/10/2021

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: MQ1413
• Device Catalogue Number: MQ1413
• Device Lot Number: 0001357081
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: UNKNOWN
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other