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

Model Number	MQ1825
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.The manufacturing location was selected as unknown due to system limitations.The manufacturing location for the mission product is bd-(b)(4).Medical device (expiry date: 07/2023).
Event or Problem Description
It was reported that during a prostate biopsy procedure, the device needle allegedly broken.There was no reported patient injury.
Event or Problem Description
It was reported that during a prostate biopsy procedure, the device needle allegedly broken.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one marquee disposable core biopsy instrument has been received.On visual evaluation, the device appeared to have residue on the sample notch.The cannula of the device was noted to be detached from the instrument.The penetration depth marker was set to 25mm.The device was received half-energized as reflected on the fire ready indicator.No other visual anomalies were noted to the device.Two electronic photos were provided and reviewed.Both photos show the marquee device, and the cannula of the device was noted to be detached from the instrument and kept aside of the device.Therefore, based on the photo review and sample evaluation, the investigation is confirmed for the reported break as the cannula of the device was noted to be detached from the instrument.The definitive root cause for the alleged break could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: the manufacturing location was selected as unknown due to system limitations.The manufacturing location for the mission product is bd-santo domingo.H10: d4 (expiry date: 07/2023), g3.H11: h6 (method, result, conclusion).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.H3 other text : see h10.

• 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; BR
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12621639
• Report Number: 2020394-2021-01863
• Device Sequence Number: 16494374
• Product Code: KNW
• UDI-Device Identifier: 00801741097225
• UDI-Public: (01)00801741097225
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K133948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2021

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: MQ1825
• Device Catalogue Number: MQ1825
• Device Lot Number: 0001375191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Male