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

Catalog Number	121610
Medical Device Problem Codes	Self-Activation or Keying (1557); Device Misassembled During Manufacturing /Shipping (2912); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2023
Type of Reportable Event	Malfunction
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: received one monopty disposable core biopsy instrument for evaluation.During visual evaluation, the device appeared to be clean and the device was received in its initial position.There were no visual anomalies noted on the device.Upon functional testing, it was noted that when priming the device - the cannula of device was self-activated.Upon dimensional observation, the cannula tang width and the stylet tang width were measured; in which both the measurements were not within specification.Therefore, the investigation is inconclusive for the reported device misassembled during manufacturing /shipping issue as there is no objective evidence for the reported issue; also, the investigation for the reported insufficient information is confirmed for the identified self-activation issue as the device self-activated when priming the device.Per the evaluation results, the tang width (both for the cannula hub and the stylet hub) measured under the specified range.This condition, which can occur as a result of compression of the tangs (and could be attributed to the reported received condition), likely contributed to the identified self-activation.However, the definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 05/2025) h11: section a through f ¿ the information provided 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.
Event or Problem Description
It was reported that prior to an ultrasound guided breast biopsy procedure, the device was allegedly already armed at the opening and does not work.The procedure was completed using another device.There was no patient contact.

• Brand Name: MONOPTY
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 85281
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18370663
• Report Number: 2020394-2023-01309
• Device Sequence Number: 20775152
• Product Code: KNW
• UDI-Device Identifier: 00801741084607
• UDI-Public: (01)00801741084607
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 12/20/2023

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 Catalogue Number: 121610
• Device Lot Number: REGT6099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2022
• 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