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

Model Number	MQ1610
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location was selected as unknown due to system limitations.The manufacturing location for this product is bd-santo domingo.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer.The investigation of the reported event is currently underway.(expiry date: 03/2028).
Event or Problem Description
It was reported that prior to a biopsy procedure, the needle allegedly had foreign substance.There was no patient contact.
Additional Manufacturer Narrative
H10: the manufacturing location was selected as unknown due to system limitations.The manufacturing location for this product is bd-santo domingo.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 was returned for evaluation.The device appeared clean and was received with protective tubing.The penetration depth marker was set to 18mm.The device was completely energized.A unknown material was noted on the stylet in the preliminary evaluation photos.Due to the decontamination of the device, visual evaluation was not conducted.Therefore, the investigation for the reported device contamination is inconclusive as the condition at time of opening is unknown and the identity of the material, or where the material came from is also unknown.A definitive root cause for the alleged device contamination could not be determined based upon the provided 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: d4 (expiry date: 03/2028), g3, h6 (method).H11:section a through f - the information provided by bd represents all of 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 or Problem Description
It was reported that prior to a biopsy procedure, the needle allegedly had foreign substance.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
• Manufacturer (Section G): UNKNOWN; BR
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13730166
• Report Number: 2020394-2022-00156
• Device Sequence Number: 11885736
• Product Code: KNW
• UDI-Device Identifier: 00801741097164
• UDI-Public: (01)00801741097164
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2022

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: MQ1610
• Device Catalogue Number: MQ1610
• Device Lot Number: 0001411978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/16/2022
• Supplement Date Received by Manufacturer: 05/07/2022
• Initial Report FDA Received Date: 03/11/2022
• Supplement Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2022
• 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