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

Catalog Number	211610
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2023
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 return of the sample is pending.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 prior to a biopsy procedure, the needle was allegedly fired without pressing the firing button.There was no patient contact.
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 unsealed and five sealed monopty disposable core biopsy instrument were returned for evaluation.Only the unsealed sample will be considered for evaluation as the remaining five samples were returned in a sealed condition.During visual testing, device appeared to be clean, received in its initial position and no other visual anomalies were noted to the unsealed samples.Upon functional testing, sample was functionally tested by twisting the rotational knob once and the cannula retracted and locked into place.Stylet retracted when the rotational knob was turned once more.By cocking and firing a couple of times the device was further tested.Device was able to be fully primed and fired without any issues and the device did not self-activate.The device was further tested by disassembling and inspecting the internal parts and no anomalies were noted to the hubs also no further testing performed.Therefore, the investigation for the reported self-activation cannot be confirmed as the device did not self-activated during functional testing.A definitive root cause for the alleged self-activation could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: b5, d4 (expiry date: 02/2026), g3.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 prior to a biopsy procedure, the needle was allegedly fired without pressing the firing button.The rotation of the grip felt uncomfortable.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 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: 18129729
• Report Number: 2020394-2023-01036
• Device Sequence Number: 17733652
• Product Code: KNW
• UDI-Device Identifier: 00801741084713
• UDI-Public: (01)00801741084713
• 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): 01/23/2024

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 Catalogue Number: 211610
• Device Lot Number: REHQ1613
• 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: 10/18/2023
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 02/05/2024
• 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: Unknown