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

Model Number MQ1413

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/22/2021

Event Type  malfunction  

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 Description

It was reported that prior to a biopsy procedure, the device button allegedly fell off.There was no patient contact.

• 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): UNKNOWN; BR
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 11492235
• MDR Text Key: 240040602
• Report Number: 2020394-2021-00569
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741097140
• UDI-Public: (01)00801741097140
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K133948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MQ1413
• Device Catalogue Number: MQ1413
• Device Lot Number: 0001357081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: UNKNOWN
• Patient Sequence Number: 1
• Patient Outcome(s): Other