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

Model Number	MQK1410
Medical Device Problem Codes	Difficult to Remove (1528); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a breast biopsy procedure, the needle allegedly bent.It was further reported that the needle was difficult to remove from coaxial and breast.There was no reported patient injury.
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 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.(expiry date: 08/2024).
Event or Problem Description
It was reported that during a breast biopsy procedure, the needle was allegedly bent.It was further reported that the needle was difficult to remove from coaxial and breast.There was no reported patient injury.
Additional Manufacturer Narrative
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 and compatible coaxial was returned to evaluation.During visual evaluation, the device appeared to have blood residue.Upon evaluation, compatible coaxial was noted to be stuck onto the needle and was not removable.Further it was noted that cannula tip was noted to be bent.Functional testing was not performed due to the condition of the returned device.Therefore, the investigation is confirmed for the reported bent needle issue and difficult to remove needle from the coaxial, as needle could not be removed from the coaxial but the reported difficult to remove from the breast cannot be confirmed as conditions of use cannot be replicated.One electronic photo was provided and reviewed.The provided photo shows the coaxial needle along with the distal tip of the mission needle which appears to be bloody.On further review, distal tip of the mission needle noted to be bent.Therefore, based on the photo review reported bent needle can be confirmed.However, the reported difficult to remove cannot be confirmed with the provided photo.The definitive root cause 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: the manufacturing location was selected as unknown due to system limitations.The manufacturing location for this product is bd-santo domingo.H10: d4(expiry date: 08/2024), g3.H11: h6 (method, result, conclusion).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.

• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 14849762
• Report Number: 2020394-2022-00522
• Device Sequence Number: 20032251
• Product Code: KNW
• UDI-Device Identifier: 00801741097287
• UDI-Public: (01)00801741097287
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 07/18/2022

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: MQK1410
• Device Catalogue Number: MQK1410
• Device Lot Number: 0001431354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2022
• Supplement Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2021
• 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