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

Catalog Number	211816
Medical Device Problem Codes	Self-Activation or Keying (1557); Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
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 biopsy needle.During visual evaluation, appeared to be clean.The monopty disposable core biopsy instrument was received in its initial position.On functional testing the device was able to prime and fire properly.No sample was obtained in the first functional test.Also, the sample 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 retracted as expected.The device was able to be fully primed with no issues and the arrow was visible in the ready window.Upon firing, the device self-activated.Therefore, the investigation is conformed for the reported failure to obtain sample as the no sample was obtained in the first functional test.Also, the investigation is identified for the self-activation as the firing, the device self-activated.The cannula fired and the stylet did not.A definitive root cause for the alleged failure to obtain sample and self-activation could not be determined based upon the provided information.It is unknown whether patient and/or procedural issues contributed to the reported event.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 of 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 a biopsy procedure, the device allegedly failed to obtain sample.The procedure was completed using another device.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: 19792438
• Report Number: 2020394-2024-01076
• Device Sequence Number: 15228101
• Product Code: KNW
• UDI-Device Identifier: 00801741084751
• UDI-Public: (01)00801741084751
• 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): 07/03/2024

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: 03/31/2026
• Device Catalogue Number: 211816
• Device Lot Number: REHR1107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2023
• 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