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

Model Number	MQ1820
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As this malfunction is considered one event identified by the dealer; only one mdr report will be submitted for the reported quantity affected of seven hundred and ninety for this event.The manufacturing location was selected as unknown due to system limitations.The manufacturing location for the marquee 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 not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 03/2025).
Event or Problem Description
It was reported that prior to a biopsy procedure, the device label was found mislabeled.There was no patient contact.
Event or Problem Description
It was reported that prior to a biopsy procedure, the device label was allegedly mislabeled.There was no patient contact.
Additional Manufacturer Narrative
H10: as this malfunction is considered one event identified by the dealer; only one mdr report will be submitted for the reported quantity affected of seven hundred and ninety for this event.H10: the manufacturing location was selected as unknown due to system limitations.The manufacturing location for the marquee 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: the physical device was not returned for evaluation.Two electronic photo(s) were provided and reviewed.The first photo shows that a marquee disposable core biopsy instrument package, end face label was noted which in the label - catalog number# : mq1810 & lot : 0001462724.The second photo shows that a marquee disposable core biopsy instrument package, front face label was noted which in the label - catalog number# : mq1820 & lot : 0001462724.And, the front face labelling information which verifies/matches with the tw details.It was noted that in both the photos, the lot number was same but the catalog number differs from each other.Based on the photo review, the reported device markings / labelling problem issue can be confirmed.Therefore, the investigation is confirmed for the reported device markings / labelling problem as the catalog number was noted to be different between the front face label and the end face label in the provided photos for review.A definitive root cause for the alleged device markings/ labelling problem 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: 03/2025), g3, h6 (method).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.

• 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: 16333710
• Report Number: 2020394-2023-00057
• Device Sequence Number: 17747280
• Product Code: KNW
• UDI-Device Identifier: 00801741097218
• UDI-Public: (01)00801741097218
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2023

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: MQ1820
• Device Catalogue Number: MQ1820
• Device Lot Number: 0001462724
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2023
• Supplement Date Received by Manufacturer: 03/18/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2022
• 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