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

Catalog Number	211610
Medical Device Problem Codes	Nonstandard Device (1420); Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: 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 for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiry date: 02/2026).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.
Event or Problem Description
It was reported that during an ultrasound-guided breast biopsy procedure, when the green grip was turned twice for setting, the outer cylinder of the device allegedly fired on its own.A coaxial was not used.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.Investigation summary: one monopty disposable core biopsy instrument was received for evaluation.During visual evaluation, the device appeared to have residue on the outer housing and the device was received in its initial position.Upon functional testing, the device was functionally tested by twisting the rotational knob once and the cannula retracted and locked into place.The rotational knob was turned once more, and the stylet did not lock into place.It fired before it was fully primed.The device was further tested by disassembling and inspecting the internal parts.No anomalies were noted to the hubs.During dimensional observations, the cannula outer tang width and stylet outer tang width were measured and were found to be not within the specification limit.Therefore, the investigation is confirmed for the reported self-activation issue as the device fired before it was fully primed.And the investigation is confirmed for the identified nonstandard device issue as the measurements of tang widths were out of specification.A definitive root cause for identified nonstandard device issue is determined to be manufacturing related was issued to the manufacturer.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.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 during an ultrasound-guided breast biopsy procedure, when the green grip was turned twice for setting, the outer cylinder of the device allegedly fired on its own.A coaxial was not used.There was no reported patient injury.

• Brand Name: MONOPTY
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 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: 19102705
• Report Number: 2020394-2024-00504
• Device Sequence Number: 7408190
• Product Code: KNW
• UDI-Device Identifier: 00801741084713
• UDI-Public: (01)00801741084713(11)230519(17)260228(10)REHQ1613
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/19/2024

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 Expiration Date: 02/28/2026
• Device Catalogue Number: 211610
• Device Lot Number: REHQ1613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/27/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 04/13/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2023
• 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: Female