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

Model Number	121610
Medical Device Problem Codes	Failure to Prime (1492); Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one monopty disposable core biopsy instrument was returned to evaluation.During visual evaluation, the device appeared to be clean and the device was received in second rotational position with the arrow in the ready window.Upon functional testing, the device was not able to prime correctly.When priming, the rotational knob would go around once, leaving the sample notch exposed.When twisting the knob again it would fire automatically.Further, functional testing was not performed.Upon dimensional observation, the cannula tang was measured and the measurement was not within acceptable range.Upon additional evaluation, also the cannula tang measurement was not within acceptable range.This is due to the repeated/prolonged compression of device may have changed the dimension from the time of production.Also, the microscopic photos shows that there are no molding issues (i.E.Short shot); therefore the width can be reduced slightly over time with normal use potentially causing the changes in cannula tang measurement.Therefore, the investigation is confirmed for the identified self-activation as the device fired automatically, when twisting the knob.Also, the investigation is confirmed for the reported failure to prime as the device was not fully primed correctly.A definitive root cause for the alleged failure to prime and identified self-activation issues 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.(expiry date: 12/2024).
Event or Problem Description
It was reported that during a biopsy procedure, the device allegedly failed to prime.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: 16281991
• Report Number: 2020394-2023-00023
• Device Sequence Number: 4779104
• Product Code: KNW
• UDI-Device Identifier: 00801741084607
• UDI-Public: (01)00801741084607
• 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
• Report Date (Section B): 01/13/2023

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: 121610
• Device Catalogue Number: 121610
• Device Lot Number: REGN2454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Male